| D | E | F | Q | R | S | T | U | V | W | X | Y | Z | AA | AB | AC | AD | AE | AF | AG | AH | AI | AJ | AK | AL | AM | AN | AO | AP | AQ | AR | AS | AT | AU | AV | AW | AX | AY | AZ | BA | BB | BC | BD | ||
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1 | PRE-ASESSMENT | PROJECT ASSIGNMENT | SUBMISSION | APPROVAL | Status Reg. | Progress Report | PICAPA | |||||||||||||||||||||||||||||||||||||
2 | ||||||||||||||||||||||||||||||||||||||||||||
3 | Country | Project Owner | Product Name | Activity Reg (NP/VAR/RENEWAL) | Type of Registration | PIC I | PIC II | PIC III | AP/NON AP | Target | BE/Challenge Target | Actual | AP/NON AP | Target | BE/Challenge Target | Actual | Jan-24 | Feb-24 | Mar-24 | Apr-24 | May-24 | Jun-24 | Jul-24 | Aug-24 | Sep-24 | Oct-24 | Nov-24 | Jan-23 | Feb-23 | Mar-23 | Apr-23 | May-23 | Jun-23 | Jul-23 | Aug-23 | Sep-23 | Oct-23 | Nov-23 | Dec-23 | Problem Identification | Corrective Action | Preventive Action | ||
4 | Malaysia | IGK | Avamab 100 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Jan-23 | Jan-23 | AP | Jun-24 | Jun-24 | Received 4th DL from NPRA, will submit the feedback on W1 of Feb 2024 | Received 5th DL. Will submit the feedback on early March 2024. | Under evaluation | Under evaluation | All the requested documents has been provided by W3 of May. Waiting for approval | Approved. In the preparation for variation submission | Done | Done | Done | Done | Done | ||||||||||||||||||||
5 | Philippines | IGK | Avamab 100 mg | SRegVar | Variations on DS,DP batch size, manufacturing process changes etc | OLF | ANR | AP | Dec-24 | May-24 | NON AP | Jun-25 | Documents preparation | Documents preparation | Submitted to consultant for her review | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | Waiting for preassessment result | Waiting for preassessment result | Waiting for preassessment result | Moved to Evaluation Proper | Evaluation | Under Evaluation by FDA | |||||||||||||||||||||
6 | Philippines | IGK | Avamab 100 mg | SRegVar | Many changes including change from ARG to SPA site | OLF | ANR | AP | Mar-24 | May-24 | NON AP | Mar-25 | Documents preparation | Documents preparation | Submitted to consultant for her evaluation | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | Waiting for preassessment result | Waiting for preassessment result | Waiting for preassessment result | Moved to Evaluation Proper | Evaluation | Under Evaluation by FDA | |||||||||||||||||||||
7 | Thailand | IGK | Avamab 100 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Oct-23 | Sep-23 | NON AP | Sep-25 | May-24 | Mar-24 | Under evaluation | Under evaluation | Approved | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | |||||||||||||||||||
8 | Vietnam | IGK | Avamab 100 mg | SRegNP | AHT | FTI | GRA | AP | Apr-24 | Sep-24 | Dec-24 | NON AP | Apr-27 | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | On process review documents | On the preparation for GMP Application | On the preparation for GMP Application | On the preparation for GMP Application | On the preparation for GMP Application | mAbxience just provided the documents in the W4 of Nov. Will submit the application asap | ||||||||||||||||||||
9 | Malaysia | IGK | Avamab 400 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Jan-23 | Jan-23 | AP | Jun-24 | Jun-24 | Received 4th DL from NPRA, will submit the feedback on W1 of Feb 2024 | Received 5th DL. Will submit the feedback on early March 2024. | Under evaluation | Under evaluation | All the requested documents has been provided by W3 of May. Waiting for approval | Approved. In the preparation for variation submission | Done | Done | Done | Done | Done | ||||||||||||||||||||
10 | Philippines | IGK | Avamab 400 mg | SRegVar | Variations on DS,DP batch size, manufacturing process changes etc | OLF | ANR | AP | Dec-24 | May-24 | NON AP | Jun-25 | Documents preparation | Documents preparation | Submitted to consultant for her review | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | Waiting for preassessment result | Waiting for preassessment result | Waiting for preassessment result | Moved to Evaluation Proper | Waiting for pre-assessment result | Under Evaluation by FDA | |||||||||||||||||||||
11 | Philippines | IGK | Avamab 400 mg | SRegVar | Many changes including change from ARG to SPA site | OLF | ANR | AP | Mar-24 | May-24 | NON AP | Mar-25 | Documents preparation | Documents preparation | Submitted to consultant for her evaluation | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | Waiting for preassessment result | Waiting for preassessment result | Waiting for preassessment result | Moved to Evaluation Proper | Waiting for pre-assessment result | Under Evaluation by FDA | |||||||||||||||||||||
12 | Thailand | IGK | Avamab 400 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Oct-23 | Sep-23 | NON AP | Sep-25 | May-24 | Mar-24 | Under evaluation | Under evaluation | Approved | Documents preparation for variation submission | Documents preparation for variation submission | Documents preparation for variation submission | Done | Done | Done | Done | Done | |||||||||||||||||||
13 | Vietnam | IGK | Avamab 400 mg | SRegNP | AHT | FTI | GRA | AP | Apr-24 | Sep-24 | Dec-24 | NON AP | Apr-27 | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | On process review documents | On the preparation for GMP Application | On the preparation for GMP Application | On the preparation for GMP Application | On the preparation for GMP Application | mAbxience just provided the documents in the W4 of Nov. Will submit the application asap | ||||||||||||||||||||
14 | Myanmar | KGM | BWFI | SRegNp | AHT | FTI | GRA | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | - | - | - | - | Pending documents from manufacturing site | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | |||||||||||||||||||||||
15 | Thailand | KGM | BWFI | SRegNp | AHT | FTI | GRA | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | - | - | - | - | Pending documents from manufacturing site. The registration in Thailand will be started after Indonesia approval | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | |||||||||||||||||||||||
16 | Cambodia | KGM | BWFI | SRegNp | AHT | FTI | GRA | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | - | - | - | - | Pending documents from manufacturing site | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | |||||||||||||||||||||||
17 | Philippines | KGM | BWFI | SRegNp | OLF | ANR | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | Waiting for documents | Waiting for documents | Waiting for documents | Waiting for documents | Waiting for documents | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | ||||||||||||||||||||||||
18 | Singapore | KGM | BWFI | SRegNp | OLF | ANR | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | Waiting for documents | Waiting for documents | Waiting for documents | Waiting for documents | Waiting for documents | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | ||||||||||||||||||||||||
19 | Vietnam | KGM | BWFI | SRegNp | AHT | FTI | GRA | NON AP | Dec-24 | Q2-2025 | NON AP | Q2-2026 | - | - | - | Pending documents from manufacturing site | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | BWFI will be submitted after received approval for BWFI ID est. in Q1 2025 | ||||||||||||||||||||||||
20 | Malaysia | KGM | Hertumab 150 mg | SRegNp | AHT | FTI | GRA | AP | Apr-24 | TBC | NON AP | Apr-26 | Documents preparation | Documents preparation. Waiting BD Confirmation | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | |||||||||||||||||||||
21 | Philippines | KGM | Hertumab 150 mg | AprvlRegNp | OLF | ANR | NON AP | Feb-22 | Feb-22 | AP | Mar-24 | Jan-24 | Approved | Approved | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||
22 | Philippines | KGM | Hertumab 150 mg | SRegVar | All variations from 2022 and 2023 | OLF | ANR | AP | May-24 | Aug-24 | Sep-2024 | NON AP | May-25 | Documents preparation | Documents preparation | Documents preparation | To forward dossier to consultant for internal evaluation | Dossier sent to consultant for Internal evaluation. requested submission date from FDA | Dossier sent to consultant for Internal evaluation. requested submission date from FDA | Dossier sent to consultant for Internal evaluation. requested submission date from FDA Aug-24 | Dossier sent to consultant for Internal evaluation. requested submission date from FDA Aug-24 | submitted for pre-assessment | Waiting for pre-assessment result | Under Evaluation by FDA | ||||||||||||||||||||
23 | Malaysia | KGM | Hertumab 420 mg | SRegNp | AHT | FTI | GRA | AP | Apr-24 | TBC | NON AP | Apr-26 | Documents preparation | Documents preparation. Waiting BD Confirmation | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | |||||||||||||||||||||
24 | Cambodia | IGK | Hertumab 60 mg | SRegNp | AHT | FTI | GRA | AP | Apr-24 | TBC | NON AP | Aug-25 | Nov-24 | - | Waiting BD confirmation | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | ||||||||||||||||||||
25 | Malaysia | IGK | Hertumab 60 mg | SRegNp | AHT | FTI | GRA | NON AP | Apr-24 | Feb-24 | NON AP | Sep-25 | - | - | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | |||||||||||||||||||||
26 | Myanmar | IGK | Hertumab 60 mg | SRegNp | AHT | FTI | GRA | AP | May-24 | TBC | NON AP | May-26 | - | Waiting BD confirmation | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | |||||||||||||||||||||
27 | Thailand | KGM | Hertumab 60 mg | SRegNp | AHT | FTI | GRA | NON AP | Mar-24 | NON AP | Mar-26 | - | Documents preparation | Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | ||||||||||||||||||||||
28 | Vietnam | KGM | Hertumab 60 mg | SRegNp | AHT | FTI | GRA | NON AP | May-24 | NON AP | May-27 | - | Waiting BD confirmation | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | Documents preparation. Pending confirmation to start the registration process | ||||||||||||||||||||||
29 | Cambodia | KGM | Trazher 150 mg | SRegVar/AprvlRegVar | Quality Updates | AHT | FTI | GRA | AP | Feb-24 | Jan-24 | AP | Aug-24 | Jan-24 | Consultant confirmed that the changes can be implemented directly | Documents preparation | The documents has been shared to consultant | Confirmed to implement all the variations | - | - | - | - | - | - | - | |||||||||||||||||||
30 | Thailand | KGM | Trazher 150 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Jan-23 | Jan-23 | NON AP | Jan-25 | Apr-24 | Dec-23 | Approved in Dec-23 | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||
31 | Thailand | KGM | Trazher 150 mg | SRegVar/AprvlRegVar | Quality Updates | AHT | FTI | GRA | NON AP | Jan-24 | Feb-24 | NON AP | Sep-24 | Apr-24 | Under preparations | Submitted on Feb-24 | Under evaluation | Approved | - | - | - | - | - | - | - | |||||||||||||||||||
32 | Thailand | KGM | Trazher 150 mg | SRegVar/AprvlRegVar | Major Quality Updates | AHT | FTI | GRA | NON AP | Jan-24 | Mar-24 | NON AP | Sep-24 | Apr-24 | Under preparations | Under preparations | Submitted on Mar-24 | Approved | - | - | - | - | - | - | - | |||||||||||||||||||
33 | Thailand | KGM | Trazher 150 mg | SRegVar/AprvlRegVar | Change of AW Dimension | AHT | FTI | GRA | NON AP | Jan-24 | Mar-24 | NON AP | Sep-24 | Apr-24 | Under preparations | Under preparations | Submitted on Mar-24 | Approved | - | - | - | - | - | - | - | |||||||||||||||||||
34 | Vietnam | KGM | Trazher 150 mg | SRegNp | AHT | FTI | GRA | AP | Apr-24 | Aug-24 | Aug-24 | NON AP | Apr-27 | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | Has shared the registration documents to local partner. Under evaluation | Under evaluation. Will submit the GMP Assessment in July. | Under evaluation. | Submitted. | Under evaluation. | Under evaluation. | Under evaluation. | ||||||||||||||||||||
35 | Cambodia | KGM | Trazher 420 mg | SRegVar/AprvlRegVar | Quality Updates | AHT | FTI | GRA | AP | Feb-24 | Jan-24 | AP | Aug-24 | Jan-24 | Consultant confirmed that the changes can be implemented directly | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||
36 | Singapore | KGM | Trazher 420 mg | SRegRen/AprvlRegRen | OLF | ANR | AP | Nov-24 | Nov-24 | AP | Dec-24 | Nov-24 | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||
37 | Singapore | KGM | Trazher 420 mg | SRegVar/AprvlRegVar | All variations from 2023 (latest) | OLF | ANR | AP | Feb-24 | Feb-24 | AP | Oct-24 | Jul-24 | Compiling variations | Submitted | Received total 2 approvals, 2 input requests | Received total 2 approvals, 2 input requests | Pending approval | Pending approval | Approved | Approved | Approved | Approved | Approved | ||||||||||||||||||||
38 | Thailand | KGM | Trazher 420 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Mar-23 | Mar-23 | NON AP | Mar-25 | Apr-24 | Dec-23 | Approved | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||
39 | Thailand | KGM | Trazher 420 mg | SRegVar/AprvlRegVar | Quality Updates | AHT | FTI | GRA | NON AP | Jan-24 | Apr-24 | NON AP | Sep-24 | Under preparations | Submitted on Feb-24 | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | ||||||||||||||||||||
40 | Thailand | KGM | Trazher 420 mg | SRegVar/AprvlRegVar | CSR Updates | AHT | FTI | GRA | NON AP | Jan-24 | Apr-24 | NON AP | Sep-24 | Apr-24 | Under preparations | Under preparations | Submitted on Mar-24 | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | |||||||||||||||||||
41 | Thailand | KGM | Trazher 420 mg | SRegVar/AprvlRegVar | Change of AW Dimension | AHT | FTI | GRA | NON AP | Jan-24 | Apr-24 | NON AP | Sep-24 | Apr-24 | Under preparations | Under preparations | Submitted on Mar-24 | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | |||||||||||||||||||
42 | Vietnam | KGM | Trazher 420 mg | SRegNp | AHT | FTI | GRA | AP | Apr-24 | Aug-24 | Aug-24 | NON AP | Apr-27 | On process partner agreement | On process partner agreement | On process partner agreement | On process partner agreement | Has shared the registration documents to local partner. Under evaluation | Under evaluation. Will submit the GMP Assessment in July. | Under evaluation. The GMP application has been submitted in Aug-24 | Submitted. | Under evaluation. | Under evaluation. | Under evaluation. | ||||||||||||||||||||
43 | Philippines | IGK | Bevacizumab 100mg (New Brand Name) | SRegNp | OLF | ANR | AP | Mar-24 | May-24 | NON AP | Mar-26 | Documents preparation | Documents preparation | Submitted to consultant for her review | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | for Resubmission. Pending submission date July 2024 | Resubmitted. For Pre-assessment result | Resubmitted. For Pre-assessment result | Moved to Evaluation Proper | Evaluation | Under Evaluation by FDA | ||||||||||||||||||||||
44 | Philippines | IGK | Bevacizumab 400mg (New Brand Name) | SRegNp | OLF | ANR | AP | Mar-24 | May-24 | NON AP | Mar-26 | Documents preparation | Documents preparation | Submitted to consultant for her evaluation | Consultant for submission to FDA may 2nd week | submitted to FDA for Pre-assessment | for Resubmission. Pending submission date July 2024 | Resubmitted. For Pre-assessment result | Resubmitted. For Pre-assessment result | Moved to Evaluation Proper | Evaluation | Under Evaluation by FDA | ||||||||||||||||||||||
45 | Cambodia | IGK | Cimaher | AprvlRegRen | AHT | FTI | GRA | AP | Jan-24 | Jan-24 | AP | Sep-24 | Submitted | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Received DL. Additional documents under preparations | Received DL. Additional documents under preparations | Received DL. Additional documents under preparations | |||||||||||||||||||||
46 | Myanmar | IGK | CIMaher | SRegVar/AprvlRegVar | Quality Updates | AHT | FTI | GRA | AP | Mar-24 | Sep-24 | AP | Nov-24 | Dec-2024 | Pending docs from CIM | Pending docs from CIM | Pending docs from CIM | Shared the documents to RA Country. | Under evaluation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | |||||||||||||||||||
47 | Myanmar | IGK | CIMaher | SRegRen | AHT | FTI | GRA | NON AP | Jan-25 | NON AP | Aug-25 | Will be submitted in 2025 | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||
48 | Cambodia | KGB | Efesa 0.3 mg/0.3 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Dec-23 | NON AP | Apr-25 | Dec-24 | On Evaluation brand name clearance | On Evaluation brand name clearance | On Evaluation brand name clearance | On Evaluation brand name clearance | Brand name clearance been approved on 23 April 2024, processing sample evaluation | Brand name clearance been approved by 23 Apr 24 | Sample been shipped on 13 May 2024 | Sample been shipped on 13 May 2024 | On Evaluation | Dossier Submission: 7 Oct 2024 Commitee Meeting proposal: W1 Nov 2024 | Dossier Submission: 7 Oct 2024 Commitee Meeting proposal: W1 Nov 2024 | ||||||||||||||||||||
49 | Malaysia | KGB | Efesa 0.3 mg/0.3 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Dec-23 | NON AP | Dec-25 | On evaluation screening process | Received screening remarks by 31 Jan 2024 and will be submitted around W3 Mar 2024. Preparing for Pre-Submission Meeting Application est Mar 2024 | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: W1 Apr 2024 | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: W1 Apr 2024 | PSM done on 19 March 2024, MDA feedback been answered to Kalbe Malaysia on 15 April 2024, Kalbe Malaysia still processing it | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: 20 June 2024 | Screening approved. MDA approved. Manual submission : 22 Jul 2024 | Screening approved. MDA approved. Manual submission : 22 Jul 2024 | On evaluation | On evaluation | On evaluation | |||||||||||||||||||||
50 | Myanmar | KGB | Efesa 0.3 mg/0.3 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Mar-24 | NON AP | Jun-26 | Waiting for import permit release | Waiting for import permit release | Sample submit: 11 March 2024 Dossier submit: 26 March 2024 | Sample submit: 11 March 2024 Dossier submit: 26 March 2024 | Sample has been submitted on 27 Mar 2024 | Sample submit: 11 March 2024 Dossier submit: 13 May 2024 | On evaluation | On Evaluation | On evaluation | On evaluation | On evaluation | |||||||||||||||||||||
51 | Philippines | KGB | Efesa 0.3 mg/0.3 mL | SRegNp | OLF | ANR | AP | Jan-24 | Mar-24 | Jul-24 | NON AP | Jan-26 | Registration documents under preparation | Pending agreement | Pending Agreement; dossier submitted to Atty. Lorna, for her evaluation | Forwarded to consultant for Internal evaluation | for internal evaluation of consultant | for internal evaluation of consultant | Submitted. For Pre-assessment result | Submitted. For Pre-assessment result | Waiting for Pre assessment result | Under Evaluation by FDA | Under Evaluation by FDA | |||||||||||||||||||||
52 | Cambodia | KGB | Efesa 0.6 mg/0.6 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Dec-23 | NON AP | Apr-25 | Dec-24 | On Evaluation brand name clearance | On Evaluation brand name clearance | On Evaluation brand name clearance | On Evaluation brand name clearance | Brand name clearance been approved on 23 April 2024, processing sample evaluation | Brand name clearance been approved by 23 Apr 24 | Sample been shipped on 13 May 2024 | Sample been shipped on 13 May 2024 | On Evaluation | Dossier Submission: 7 Oct 2024 Commitee Meeting proposal: W1 Nov 2024 | Dossier Submission: 7 Oct 2024 Commitee Meeting proposal: W1 Nov 2024 | ||||||||||||||||||||
53 | Malaysia | KGB | Efesa 0.6 mg/0.6 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Dec-23 | NON AP | Dec-25 | On screening evaluation | Received screening remarks by 31 Jan 2024 and will be submitted around W3 Mar 2024. Preparing for Pre-Submission Meeting Application est Mar 2024 | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: W1 Apr 2024 | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: W1 Apr 2024 | PSM done on 19 March 2024, MDA feedback been answered to Kalbe Malaysia on 15 April 2024, Kalbe Malaysia still processing it | Pre submission meeting: 19 March 2024 Submit NPRA feedback: 26 March 2024 Submit MDA feedback: 20 June 2024 | Screening approved. MDA approved. Manual submission : 22 Jul 2024 | Screening approved. MDA approved. Manual submission : 22 Jul 2024 | On evaluation | On evaluation | On evaluation | |||||||||||||||||||||
54 | Myanmar | KGB | Efesa 0.6 mg/0.6 mL | SRegNp | AHT | FTI | JSA | NON AP | Dec-23 | Mar-24 | NON AP | Jun-26 | Dec-25 | Waiting for import permit release | Waiting for import permit release | Sample submit: 11 March 2024 Dossier submit: 26 March 2024 | Sample submit: 11 March 2024 Dossier submit: 26 March 2024 | Sample has been submitted on 27 Mar 2024 | Sample submit: 11 March 2024 Dossier submit: 13 May 2024 | On evaluation | On Evaluation | On evaluation | On evaluation | On evaluation | ||||||||||||||||||||
55 | Philippines | KGB | Efesa 0.6 mg/0.6 mL | SRegNp | OLF | ANR | AP | Jan-24 | Jul-24 | NON AP | Jan-26 | Registration documents under preparation | Pending agreement | Pending Agreement; dossier submitted to Atty. Lorna, for her evaluation | Forwarded to consultant for Internal evaluation | for internal evaluation of consultant | for internal evaluation of consultant | Submitted. For Pre-assessment result | Submitted. For Pre-assessment result | Waiting for Pre assessment result | Under Evaluation by FDA | Under Evaluation by FDA | ||||||||||||||||||||||
56 | Malaysia | KGM | Ezelin PFP | SRegNp | AHT | FTI | GRA | AP | Jan-24 | Jul-24 | NON AP | Jan-26 | pending dossier. Will be submitted in Feb-24 | Documents preparation | Documents preparation | Documents preparation. | Documents preparation. | Will be submitted in July. | Submitted. Under evaluation | Submitted. Under evaluation | Submitted. Under evaluation | Submitted. Under evaluation | Submitted. Under evaluation | |||||||||||||||||||||
57 | Maldives | KGM | Ezelin PFP | SRegNp | AHT | FTI | GRA | NON AP | Apr-24 | NON AP | Apr-26 | - | Documents preparation | Pending confirmatio to start the registrayopm | Pending confirmatio to start the registrayopm | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | ||||||||||||||||||||||
58 | Myanmar | KGM | Ezelin PFP | SRegVar/AprvlRegVar | Addition of Pre Filled Pen | AHT | FTI | GRA | AP | Jan-24 | Jan-24 | AP | Sep-24 | Jul-24 | Submitted | Under evaluation | Under evaluation | Under evaluation | Received preview of approval. Est. will get the updated certificate in Jul-24 | Received preview of approval. Est. will get the updated certificate in Jul-24 | Approved | Approved | Approved | Approved | Approved | |||||||||||||||||||
59 | Philippines | KGM | Ezelin PFP | SRegNp | OLF | ANR | AP | Jan-24 | TBC | NON AP | Jan-26 | waiting for documents | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | On hold. Pending agreement | On hold. Pending agreement | On hold. Pending agreement | On hold. Pending agreement | On hold. Pending agreement | ||||||||||||||||||||||
60 | Sri Lanka | KGM | Ezelin PFP | SRegNp | AHT | FTI | GRA | NON AP | Aug-24 | NON AP | Aug-26 | - | Documents preparation | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | Pending approval of GMP of KGM | ||||||||||||||||||||||
61 | Thailand | KGM | Ezelin PFP | SRegNp | AHT | FTI | GRA | NON AP | May-24 | NON AP | May-26 | - | Documents preparation | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | Pending confirmatio to start the registration | ||||||||||||||||||||||
62 | Nigeria | KGM | Hemapo | AprvlRegNp | OLF | ANR | NON AP | Dec-22 | Dec-22 | AP | Dec-24 | evaluation | Documents preparation | evaluation | Pending cold-chain facility | Pending cold-chain facility | Pending cold-chain facility | Pending cold-chain facility | Finalizing cold chain facility | Waiting for Final inspection date | Waiting for Final inspection date | For re-inspection | ||||||||||||||||||||||
63 | Cambodia | KGM | Hemapo 2000 | SRegVar/AprvlRegVar | Cell Based Assay | AHT | RHA | AAS | Non AP | Mar-24 | Non AP | Sep-24 | Documents preparation | Documents preparation | Documents preparation | The change will be submitted together with Renewal in Jul 2024 (ED reg certificate : Jul-25), since there is no variation path in Cambodia | Will be submitted after received initial registration approval | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | |||||||||||||||||||||
64 | Cambodia | KGM | Hemapo 2000 | SRegVar/AprvlRegVar | New Formula | AHT | RHA | AAS | AP | Mar-24 | Oct-24 | Non AP | Sep-24 | Documents preparation | Documents preparation | Documents preparation | The change will be submitted together with Renewal in Jul 2024 (ED reg certificate : Jul-25), since there is no variation path in Cambodia | Will be submitted after received initial registration approval | Documents preparation | Documents complete and will be submitted to consultant on Aug 2024 (waiting for samples) | Dossier and sample are sent to Cambodia on 31 Aug 24 | Approval of sample clearance on 18-Sep-24. Sample will be sent to Lab on 23 Sep 24,. Est Dossier submitted to FDA on W1 Dec-24 | Submit sample on 4 Oct 2024. Dossier will be submitted est Dec-24 | Submit sample on 4 Oct 2024. Dossier will be submitted est Dec-24 | ||||||||||||||||||||
65 | Cambodia | KGM | Hemapo 2000 | SRegVar/AprvlRegVar | Alternative Manuf KDS | AHT | RHA | AAS | AP | Mar-24 | AP | Jun-24 | Documents preparation | Documents preparation | Documents preparation | The change will be submitted together with Renewal in Jul 2024 (ED reg certificate : Jul-25), since there is no variation path in Cambodia | Will be submitted after received initial registration approval | Documents preparation | Documents complete and will be submitted to consultant on Aug 2024 (waiting for samples) | Dossier and sample are sent to Cambodia on 31 Aug 24 | Approval of sample clearance on 18-Sep-24. Sample will be sent to Lab on 23 Sep 24,. Est Dossier submitted to FDA on W1 Dec-24 | Submit sample on 4 Oct 2024. Dossier will be submitted est Dec-24 | Submit sample on 4 Oct 2024. Dossier will be submitted est Dec-24 | |||||||||||||||||||||
66 | Maldives | KGM | Hemapo 2000 | SRegVar/AprvlRegVar | Cell Based Assay | AHT | RHA | AAS | Non AP | Apr-24 | Non AP | Oct-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Will be submitted after received initial registration approval | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | |||||||||||||||||||||
67 | Maldives | KGM | Hemapo 2000 | SRegNP/AprvlRegNP | New Formula | AHT | RHA | AAS | AP | Mar-24 | Oct-24 | NON AP | Mar-25 | Documents preparation | Documents preparation | Documents preparation | Change of Formula is considered under New Product Reg. We have requested the detail requirements to consultant on 4 Apr 2024 | - | Received the detail requirements from consultant on June 24, 2024; documents prepation | Submitted dossier to consultant on Jul 24, 2024. They just informed that we need to submit physical samples | Submitted dossier to consultant on Jul 24, 2024. They just informed that we need to submit physical samples | Dossier has been sent to distributor. Waiting for the import permit approval for shipment of reg sample | Submit sample on 17 Oct. Dossier has been submitted on 31 Oct 24 | Submit sample on 17 Oct. Dossier has been submitted on 31 Oct 24 | ||||||||||||||||||||
68 | Maldives | KGM | Hemapo 3000 | SRegNP/AprvlRegNP | New Formula | AHT | RHA | AAS | AP | Mar-24 | Oct-24 | NON AP | Mar-25 | Documents preparation | Documents preparation | Documents preparation | Change of Formula is considered under New Product Reg. We have requested the detail requirements to consultant on 4 Apr 2024 | - | Received the detail requirements from consultant on June 24, 2024; documents prepation | Submitted dossier to consultant on Jul 24, 2024. They just informed that we need to submit physical samples | Submitted dossier to consultant on Jul 24, 2024. They just informed that we need to submit physical samples | Dossier has been sent to distributor. Waiting for the import permit approval for shipment of reg sample | Submit sample on 17 Oct. Dossier has been submitted on 31 Oct 24 | Submit sample on 17 Oct. Dossier has been submitted on 31 Oct 24 | ||||||||||||||||||||
69 | Myanmar | KGM | Hemapo 3000 | SRegVar/AprvlRegVar | Cell Based Assay | AHT | RHA | AAS | Non AP | Feb-24 | Non AP | Oct-24 | Documents preparation | Documents preparation | Waiting for KGM confirmation | - | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Documents preparation | |||||||||||||||||||||
70 | Myanmar | KGM | Hemapo 3000 | SRegVar/AprvlRegVar | New Formula | AHT | RHA | AAS | AP | Feb-24 | Mar-24 | AP | Oct-24 | Documents preparation | Documents preparation | Need to submit hardfile, waiting for CPP | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | As confirmed by Kay Zin, the Variation cannot be submitted in parallel with Renewal, so it will be submitted after renewal approved (est Dec 2024) | ||||||||||||||||||||
71 | Myanmar | KGM | Hemapo 3000 | SRegRen/AprvlRegRen | AHT | RHA | AAS | AP | Feb-24 | Mar-24 | Apr-24 | AP | Dec-24 | Sep-24 | Documents preparation | Documents preparation | Need to submit hardfile, waiting for CPP | Submitted on 8 Apr 2024 | In process evaluation | In process evaluation | In process evaluation | In process evaluation | Reg is approved on 11-Sep-24. Reg Certificate will be issued 2 monthes after approval | Reg is approved on 11-Sep-24. Reg Certificate will be issued 2 monthes after approval | Reg is approved on 11-Sep-24. Reg Certificate will be issued 2 monthes after approval | |||||||||||||||||||
72 | Myanmar | KGM | Hertumab 150 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Aug-22 | Aug-22 | AP | Aug-24 | Nov-24 | Under evaluation | Under evaluation | Under evaluation | Under evaluation | RA KI has been discussed with FDA Director and he confirmed that Trastuzumab will be approved soon | Received Dificency Letter. Will share the supporting documents in 1st Week of July | Received Dificency Letter. Will share the supporting documents in 1st Week of July | Under evaluation. Est. approval Oct-24 | Under evaluation. Est. approval Oct-24 | Under evaluation | Approved | ||||||||||||||||||||
73 | Myanmar | KGM | Hertumab 150 mg | SRegVar | Quality Updates | AHT | FTI | GRA | AP | Sep-24 | Jan-25 | NON AP | May-25 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | ||||||||||||||||||||
74 | Myanmar | KGM | Hertumab 150 mg | SRegVar | CSR Updates | AHT | FTI | GRA | NON AP | Sep-24 | NON AP | May-25 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
75 | Myanmar | KGM | Hertumab 150 mg | SRegVar/AprvlRegVar | Change of AW Dimension | AHT | FTI | GRA | NON AP | Sep-24 | NON AP | Oct-24 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
76 | Myanmar | KGM | Hertumab 420 mg | AprvlRegNp | AHT | FTI | GRA | NON AP | Dec-22 | Dec-22 | AP | Dec-24 | Under evaluation | Documents preparation | Under evaluation | Under evaluation | RA KI has been discussed with FDA Director and he confirmed that Trastuzumab will be approved soon | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | |||||||||||||||||||||
77 | Myanmar | KGM | Hertumab 420 mg | SRegVar | Quality Updates | AHT | FTI | GRA | NON AP | Sep-24 | NON AP | May-25 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
78 | Myanmar | KGM | Hertumab 420 mg | SRegVar | CSR Updates | AHT | FTI | GRA | NON AP | Sep-24 | NON AP | May-25 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
79 | Myanmar | KGM | Hertumab 420 mg | SRegVar/AprvlRegVar | Change of AW Dimension | AHT | FTI | GRA | NON AP | Sep-24 | NON AP | Oct-24 | - | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
80 | Philippines | KGM | Hertumab 420 mg | AprvlRegNp | OLF | ANR | NON AP | Mar-23 | Mar-23 | NON AP | Mar-25 | May-24 | evaluation | Documents preparation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | Under evaluation | |||||||||||||||||||||
81 | Philippines | KGM | Hertumab 420 mg | SRegVar | All variations from 2022 and 2023 | OLF | ANR | AP | Jul-24 | Sep-2024 | NON AP | Jul-25 | waiting for aprroval | Documents preparation | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | Will be submitted after received approval | |||||||||||||||||||||
82 | Cambodia | KGM | Leucogen | SRegVar/AprvlRegVar | Update Spec AM EP 10 | AHT | RHA | AAS | AP | May-24 | 25-Apr-24 | AP | Aug-24 | May-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | |||||||||||||||||||||
83 | Cambodia | KGM | Leucogen | SRegVar/AprvlRegVar | Remove PUPSIT | AHT | RHA | AAS | AP | May-24 | 25-Apr-24 | AP | Aug-24 | May-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | |||||||||||||||||||||
84 | Cambodia | KGM | Leucogen | SRegVar/AprvlRegVar | Change Supplier Excipient | AHT | RHA | AAS | AP | May-24 | 25-Apr-24 | AP | Aug-24 | May-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | |||||||||||||||||||||
85 | Cambodia | KGM | Leucogen | SRegVar/AprvlRegVar | Change API Manufacturer Name | AHT | RHA | AAS | AP | May-24 | 25-Apr-24 | AP | Aug-24 | May-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | Received the confirmation from Sopheak on 3 May 2024 that the proposed changes can be implemented | |||||||||||||||||||||
86 | Myanmar | KGM | Leucogen | AprvlRegVar | Smaller Blister | AHT | RHA | AAS | NON AP | Nov-23 | Nov-23 | AP | Jun-24 | Feb-24 | Feb-24 | On evaluation | Approved | Approved | - | - | - | - | - | - | - | - | ||||||||||||||||||
87 | Myanmar | KGM | Leucogen | SRegVar/AprvlRegVar | Change API Manufacturer Name | AHT | RHA | AAS | AP | Feb-24 | Mar-24 | 16-May-24 | AP | Oct-24 | Nov-24 | Documents preparation | Documents preparation | Documents preparation | RA has emailed all proposed changes (change API Mfg Name, Change supplier excipient, update spec&MA to EP10, remove PUPSIT) to Kay Zin on 8 Apr 2024. Waiting for Explanation Letter and COA of excipient from new source | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | As informed by Kay Zin, the changes can be implemented | ||||||||||||||||||
88 | Myanmar | KGM | Leucogen | SRegVar/AprvlRegVar | Update Spec AM EP 10 | AHT | RHA | AAS | AP | May-24 | 16-May-24 | NON AP | Jan-25 | Documents preparation | Documents preparation | Documents preparation | RA has emailed all proposed changes (change API Mfg Name, Change supplier excipient, update spec&MA to EP10, remove PUPSIT) to Kay Zin on 8 Apr 2024. Waiting for Explanation Letter and COA of excipient from new source | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | ||||||||||||||||||||||
89 | Myanmar | KGM | Leucogen | SRegVar/AprvlRegVar | Remove PUPSIT | AHT | RHA | AAS | AP | May-24 | 16-May-24 | NON AP | Jan-25 | Documents preparation | Documents preparation | Documents preparation | RA has emailed all proposed changes (change API Mfg Name, Change supplier excipient, update spec&MA to EP10, remove PUPSIT) to Kay Zin on 8 Apr 2024. Waiting for Explanation Letter and COA of excipient from new source | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | ||||||||||||||||||||||
90 | Myanmar | KGM | Leucogen | SRegVar/AprvlRegVar | Change Supplier Excipient | AHT | RHA | AAS | AP | May-24 | 16-May-24 | NON AP | Jan-25 | Documents preparation | Documents preparation | Documents preparation | RA has emailed all proposed changes (change API Mfg Name, Change supplier excipient, update spec&MA to EP10, remove PUPSIT) to Kay Zin on 8 Apr 2024. Waiting for Explanation Letter and COA of excipient from new source | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | The Explanation Letter and some documents have been submitted to Myanmar FDA on 16 May 2024 | ||||||||||||||||||||||
91 | Singapore | IGK | M2PK medical device | SRegRen/AprvlRegRen | OLF | ANR | AP | Feb-24 | Feb-24 | AP | Mar-24 | Feb-24 | - | Renewing | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||
92 | Nigeria | KGM | Neukalgen | AprvlRegNp | OLF | ANR | NON AP | Nov-21 | Nov-21 | AP | Jun-24 | evaluation | Pending cold chain facility | Pending cold chain facility | Pending cold chain facility | Pending cold chain facility | Pending cold chain facility | Pending cold chain facility | Finalizing cold chain facility | Waiting for Final inspection date | Waiting for Final inspection date | For re-inspection | ||||||||||||||||||||||
93 | Myanmar | IGK | Rituxikal 100 | AprvlRegVar | Change to KGM Site | AHT | FTI | GRA | NON AP | Aug-23 | Aug-23 | AP | Apr-24 | Feb-24 | Under evaluation | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | |||||||||||||||||||
94 | Philippines | IGK | Rituxikal 100 | SRegVar | DS batch size changes etc | OLF | ANR | AP | Jun-24 | Mar-24 | NON AP | Jun-25 | Jun-24 | Documents preparation | Documents preparation | Done | - | Approved | Approved | Approved | Approved | Approved | Approved | |||||||||||||||||||||
95 | Philippines | IGK | Rituxikal 100 | SRegRen/AprvlRegRen | OLF | ANR | AP | May-24 | Mar-24 | NON AP | May-25 | Documents preparation | Submitted to consultant | Submitted to FDA; waiting for pre-assessment result | Submitted to FDA; waiting for pre-assessment result | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Under evaluation | Under evaluation | Under evaluation | ||||||||||||||||||||||
96 | Philippines | IGK | Rituxikal 100 | SRegVar/AprvlRegVar | Site change to KGM | OLF | ANR | NON AP | Dec-23 | AP | Dec-24 | submitted to consultant; for submission to fda | Pending NRA (BPOM) approval | Submitted to FDA; waiting for pre-assessment result | Submitted to FDA; waiting for pre-assessment result | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Drop Application | Drop Application | Drop Application | Drop Application | Drop Application | ||||||||||||||||||||||
97 | Myanmar | IGK | Rituxikal 500 | AprvlRegVar | Change to KGM Site | AHT | FTI | GRA | NON AP | Aug-23 | Aug-23 | AP | Apr-24 | Feb-24 | Under evaluation | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | Approved | |||||||||||||||||||
98 | Philippines | IGK | Rituxikal 500 | SRegVar | DS batch size changes etc | OLF | ANR | AP | Jun-24 | Mar-24 | NON AP | Jun-25 | Jun-24 | Documents preparation | Documents preparation | Documents preparation | Documents preparation | Approved | Approved | Approved | Approved | Approved | Approved | |||||||||||||||||||||
99 | Philippines | IGK | Rituxikal 500 | SRegRen/AprvlRegRen | OLF | ANR | AP | May-24 | Mar-24 | NON AP | May-25 | Documents preparation | Submitted to consultant | Submitted to FDA; waiting for pre-assessment result | Submitted to FDA; waiting for pre-assessment result | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Evaluation proper | Evaluation | Evaluation | ||||||||||||||||||||||
100 | Philippines | IGK | Rituxikal 500 | SRegVar/AprvlRegVar | Site change to KGM | OLF | ANR | NON AP | Dec-23 | Feb-24 | AP | Dec-24 | submitted to consultant; for submission to fda | Pending NRA (BPOM) approval | Submitted to FDA; waiting for pre-assessment result | Submitted to FDA; waiting for pre-assessment result | Received acceptable preassessment; moved to evaluation proper | Received acceptable preassessment; moved to evaluation proper | Drop Application | Drop Application | Drop Application | Drop Application | Drop Application | |||||||||||||||||||||