1. Gap Analysis:

Analyze gaps between target market requirements and factory conditions, and guide the factory to supplement tests/documents.

2. Technical Documentation Preparation:

Prepare registration documents according to target market requirements.

3. Feedback Handling:

Complete deficiency responses based on official feedback.

4. Post-Marketing Management:

Execute registration variations and renewals as required.

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1. Definition and Background

Africa, as one of the fastest-growing pharmaceutical markets globally, is driven by demographic dividends and the dual burden of infectious and chronic diseases, leading to increasing demand. Pharmaceutical registration in Africa refers to the process where manufacturers submit technical documentation to national regulatory authorities (e.g., SAHPRA, NAFDAC) to demonstrate quality, safety, and efficacy for market approval.

With Africa's growing population and disease burden—especially infectious and chronic diseases—drug demand has surged. However, fragmented regulations across countries necessitate aligning international standards (e.g., WHO, PIC/S) with local requirements.

2. Applicable Scope

·Drug Types: Chemical drugs, etc.

·Application Categories: New registration, renewal, variations (e.g., process changes).

3. Basic Requirements

·Target market’s GMP or SRA-country GMP

·Current market Guidelines

·Embassy-legalized certificates

·CTD/CTD-like dossiers (detail level varies by market)

·Sterile Products: Batch consistency, sterility assurance documents, USP-compliant packaging.

·Special Requirements: Import restrictions (e.g., Nigeria’s prohibited list), local production incentives.

4. Registration Process

1）Gap Analysis: Assess compliance gaps and supplement tests/docs per regulations.

2）CTD Dossier Preparation: Prepare and submit market-specific files.

3）Screening Review & Reply (if any): Authorities conduct screening (if applicable), request completeness checks, and require supplements.

4）Review & Reply: Formal evaluation with deficiency letters; respond within deadlines.

5）Approved: Obtain registration certificate for market launch.

5. Regulatory Basis

·International Standards: WHO GMP, ICH Guidelines

·Regional Examples:

South Africa: Mature market (SAHPRA)

ZAZIBONA: Member-state mutual recognition

Nigeria: Largest West African market (NAFDAC)

Ethiopia/Tanzania: Stringent regulations