Generally, API manufacturers share only the open part of the APIMF with the applicants to whom they supply the API. Applicants therefore only submit the open part of the APIMF in a new registration application. However, SAHPRA requires both the open and closed part of the APIMF to evaluate an API’s quality. Previously, obtaining the closed part necessitated back-and-forth communication with the API manufacturer through the applicant.
Going forward, SAHPRA will have an APIMF Procedure in place to avoid this and to achieve other objectives. Click here to read more[BACK TO News]