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Introduction

An Active Pharmaceutical Ingredient Master File (APIMF) contains all the required information for the quality evaluation of an API. The APIMF is comprised of two parts:

1. The Open part (applicant part): the applicant has access to this information.

2. The closed part (restricted part): the applicant does not have access to this information, it is confidential.

API suppliers share only the open part of the APIMF.
SAHPRA now requires that both the open and closed parts of the APIMF be submitted for evaluation of pre-registration and variation applications.
The APIMF Procedure will be separate from the normal application procedure.

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Current Submission Process and its Challenges

Communication delays – Applicant is a middleman between SAHPRA and the API supplier. Communication received by the applicant from SAHPRA must go to the API supplier and then submitted directly to SAHPRA by the API supplier.

Delays in assessment of new products for registration & variations:

Restricted part of the APIMF submitted much later when evaluation is in process.
Submission of PDFs that are not bookmarked and not searchable makes it difficult for the assessors to navigate through the document.
Not all the queries are adequately addressed causing further delays.
No or non-functional hyperlinks in the DMF.

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Proposed Submission Process

Applicant to request the supplier to send an expression of interest to submit the closed part through the APIMF dedicated email: APIMF@sahpra.org.za.
SAHPRA APIMF Team shares the SAHPRA APIMF numbers and login credentials with the API suppliers to upload their APIMFs.

Advantages:

Simultaneous evaluation of both the closed and open parts of the APIMF.
No delays due to the back and forth: improved turnaround times

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Proposed Submission requirements

API Suppliers

Complete the current Submission form.
Complete current Letter of access.
Amendment schedule to APIMF holder (Response for new registrations + Variations)

Changes or variations to the APIMF

API supplier’s responsibility to notify the applicants and SAHPRA about any changes to the open and closed part of the APIMF, so the applicants can update all affected dossiers accordingly and pay.

Applicant

To submit a copy of the latest version of the open part of the APIMF.
SAHPRA APIMF number should be referenced in the application letter, as well as in the relevant parts of the QIS/QOS.
Amendment schedule 1.5.2.1 for all variations and responses.
Reliance documentation should be included in module 1.10 from the approved RRAs.

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FAQs or Common Deficiencies for the API

The FAQs document is provided to assist the API suppliers to adequately address the queries raised by SAHPRA. This will reduce the evaluation timelines.

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Conclusion

Reduced evaluation times.
Reliance to avoid duplication of work where more than one application refers to the same manufacturer.
This will help to streamline the submission process of the DMF
The confidential information of the restricted part will be stored electronically, with strict access permission.
Query & Approval letter on the restricted part of the APIMF will only be shared with the API supplier.