Accelerate Registration of Medical Products

Sub-Saharan Africa continues to face major challenges in ensuring equitable access to essential medicines and health technologies. The access is constrained by high dependency on imports, limited local manufacturing capacity, weak supply chains, and inadequate infrastructure. One of the main challenges is the lack of technical capacity of National Regulatory Authorities (NRAs) to perform critical regulatory functions effectively. This results in fragmented and inefficient regulatory processes, delays in medicines registration, and limited access to quality-assured medical products.

The African Medicines Regulatory Harmonization (AMRH) Initiative leads progress in streamlining regulatory systems for medicines and health technologies, including the development of procedures for joint dossier assessments, harmonized documentation, and common digital platforms. These efforts improve regulatory efficiency, reduce registration timelines, and enhance access to safe and effective medicines across the continent.

The project aims to further strengthen regional and continental regulatory capacities, support the operationalization of the African Medicines Agency (AMA), and improve marketing authorization procedures for global health products. The AMRH Initiative has laid the foundation for AMA, transferring continental standards and tools to ensure regulatory convergence, strengthen local manufacturing, and improve access to safe, effective, and quality medical products and technologies across Africa.

Switzerland is one of the first and few donor countries combining the resources of its International Cooperation (SDC) with the ones of Switzerland’s national regulatory agency (Swissmedic). It has hence developed a competitive advantage based on its expertise, knowledge and experience in a niche, underfunded sector.

Primary beneficiaries are people in Africa who need medical products for which marketing authorisation at the level of Swissmedic, WHO prequalification programme and NRAs in Africa is sought.

Secondary beneficiaries are NRAs and RECs in Africa that benefit from technical regulatory systems strengthening support provided by WHO and Swissmedic.

Pharmaceutical companies that seek marketing authorisation for their product candidates are also secondary beneficiaries.

Outcome 1: National Regulatory Authority (NRA) capacity strengthened.

Outcome 2: Strengthened regional harmonization of regulatory systems and procedures.

Outcome 3: African Medicines Agency (AMA) functioning.

Outcome 4: Strengthened Marketing Authorization procedure for Global Health Products (MAGHP).

Principaux résultats attendus:  

1. Harmonised technical guidelines, standards and procedures are developed, regularly updated and implemented at the REC (EAC, ECOWAS, IGAD, OCEAC, SADC) and country level. The capacities of national NRAs and regional regulatory networks are strengthened.

2. Joint assessments, reviews, and joint manufacturing site inspections based on harmonised guidelines, are conducted to accelerate the approval of priority medical products and strengthen NRAs, with partner technical support efficiently coordinated by the WHO through the CIP Network and the AMRH programme.

3. The African continental regulatory framework effectively supports regional initiatives and countries, providing technical assistance to AMRH structures, Technical Committees and the operationalisation of AMA.

4. Advice from Swissmedic and MAGHP is regularly used and promoted among relevant applicants, while LMICs NRAs receive technical support to implement facilitated regulatory pathways and register products that benefit from Swissmedic and MAGHP. A Global Competency Framework for harmonized regulatory performance standards is piloted.

Principaux résultats antérieurs:  

In all Regional Economic Communities (RECs) in Africa:

50 joint assessments of 220 products conducted, 30 products recommended for registration in countries.

62 applications received for the East African Community joint assessment and registration, with 15 products recommended for national level registration.

14 joint manufacturing site inspections carried out, with 11 certificates issued.

Shorter approval times: from an average of 24 months to 12 months or less.

Coalition of Interested Parties (CIP) launched and toolkit for CIP implementation developed. 16 Expressions of Interest and 13 applications for CIP membership received. CIP web platform launched in 2021 and serves as a secure, central repository for information relating to collaboration between Member States and CIP members supporting the strengthening of in-country and regional regulatory systems.

3 products approved within the Swissmedic Market Authorisation Procedure for Global Health Products (MAGHP) 2023-2025: 1 product for post-partum haemorrhage, 1 ophthalmic anaesthetic, 1 novel antimalarial in paediatric formulation.

5 Scientific advice meetings within MAGHP procedure: 1 product for treatment of Cryptosporidium, 2 products for leishmaniasis, 2 products against malaria.