Accelerate Registration of Medical Products

Ensuring access to safe, effective, quality-assured medical products is a complex issue. Before reaching markets and patients, every new medical product and technology must undergo a specific approval process. Worldwide, medical products are submitted to the US Stringent Regulatory Authority or the European one for global approval. Along with these two agencies, the WHO also recognizes Swissmedic as a global Stringent Regulatory Authority. Lengthy assessment and approval procedures are recognized as a significant contributor to delayed access and poor health outcomes, especially in low- and middle-income countries (LMICs).

To address this problem, since 2015, SDC has engaged in strengthening medicines regulatory systems by supporting the WHO to perform joint product assessments with technical partners (including partners with long-standing expertise and experience in this sector, such as Swissmedic) in support of regional or national medicine agencies. This endeavour offers a mechanism of reducing evaluation and marketing authorization timelines, as well as increasing the transparency of product assessment. 

Primary beneficiaries are people in Africa and LMICs in other regions.

Secondary beneficiaries are NRAs and Regional Economic Communities 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 Authorities capacity strengthened

Outcome 2: Strengthened Regional and continental harmonization of regulatory systems and procedures

Outcome 3: African Medicines Agency (AMA) set up and functioning

Outcome 4: Strengthened Marketing Authorization procedure for Global Health Products

Erwartete Resultate:  

Output 1.1 Harmonized technical guidelines, standards and procedures implemented at country level.

Output 1.2 Capacities of regulatory staff of African NRAs and regional networks strengthened through acquired knowledge and skills.

Output 1.3 Global competency framework to support implementation of harmonized and quality performance standards for regulatory activities piloted.

Output 2.1 Harmonized technical guidelines, standards and procedures developed, regularly updated and implemented at Regional Economic Community (REC) by 2025.

Output 2.2 Joint assessments/reviews undertaken to accelerate regulatory approval of priority medical products at country, regional or continental level.

Output 2.3 Manufacturing site inspections of pharmaceutical companies marketing their products in the respective RECs jointly conducted by the relevant region’s(s’) NRAs according to harmonized guidelines and established standards and procedures.

Output: 2.4 WHO efficiently coordinates technical support provided by different partners to NRAs or regional regulatory networks through the CIP Network and the African Medicines Regulatory Harmonization (AMRH) Programme.

Output 2.5 Adoption of the African continental and regional regulatory harmonization framework in support of regional initiatives and countries facilitated. Technical support to continental AMRH and Technical Committees provided.

Output 3 Partners are supported in the implementation of the AMA work plan.

Output 4.1 Swissmedic scientific advice and marketing authorization procedure for global health products (MAGHP) is regularly used by relevant applicants and actively promoted and advocated.

Output 4.2 Technical advice and support to LMICs NRAs to implement facilitated regulatory pathways, including Collaborative Registration Procedure, provided. 

Resultate von früheren Phasen:  

In all Regional Economic Communities 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 (15 products recommended for registration).
• 14 joint manufacturing site inspections carried out, with 11 certificates issued.
• Reductions in timelines for marketing authorization approvals: from an average of 24 to 12 months or less.
  
• Coalition of Interested Parties (CIP) launched and CIP toolkit for CIP implementation developed. CIP web platform launched in 2021 and serving as a secure, central repository for information relating to collaboration between Member States and CIP members supporting incountry and regional regulatory system strengthening.
• Swissmedic Market Authorisation Procedure for Global Health Products (MAGHP): 1 product for post-partum haemorrhage approved. Scientific Advice for 1 product against malaria provided.