Understanding Africa's CTD Dossier Requirements: What Manufacturers Often Get Wrong

API Documentation : Key Africa Dossier Requirements Manufacturers Should Not Miss

Manufacturers sometimes focus heavily on the finished product and overlook the completeness of the API section.

🔹 APIMF/DMF: Where an APIMF procedure is applicable, the Open Part should be included in the product dossier, while the required Restricted Part should be submitted directly to Agency by the API manufacturer.

🔹 Letter of Access: Ensure a valid Letter of Access from the API manufacturer is included in Module 1.

🔹 Sterile API: Where the API is sterile, the Media Fill Validation Protocol and Report from the API manufacturer/vendor should be available as part of the supporting documentation, where applicable.

🔹 Specifications: Ensure signed and dated API and finished product specifications are available.

🔹 COAs: Provide three (03) recent Certificates of Analysis (COAs) from the API manufacturer/vendor and corresponding finished product manufacturer, as applicable.

Before dossier submission in Africa, ensure that your API source, APIMF/DMF/CEP strategy, Letter of Access, specifications, COAs, and supporting validation documents are complete, current, and consistent with the CTD dossier.

API source → API documentation → DMF/APIMF/CEP strategy → Letter of Access → Module 3 consistency