Accelerate Registration of Medical Products
Limited access to safe and efficacious quality medical products for people in low and middle-income countries has many reasons. One increasingly recognised factor are lengthy and unreliable product assessment and approval procedures for applicants. Through the Swiss Agency for Therapeutic Products and SDC, Switzerland has become one of the key partners in supporting African medicines regulatory systems become more efficient. Both will expand their engagement in Africa and globally.
A nivel mundial
Fortalecimiento del sistema sanitario
- East African Community (EAC):
62 applications received for EAC joint assessment and registration, with 15 products recommended for registration at national level
14 joint manufacturing site inspections with 11 certificates issued
Reductions in approval timelines from an average of 24 months at baseline, to 12 months or shorter
- Swissmedic Market Authorisation Procedure for Global Health Products: 2 products under evaluation (for tuberculosis and for post-partum haemorrhage)
- World Health Organization
|Contexto||Access to safe and efficacious quality medical products is a complex issue. It spans from research and development of innovative products to sustainable financing of these products and the appropriate use of the products by the patient in need. An increasingly recognised factor delaying access are lengthy assessment and approval procedures that may last up to 7 years in some low and middle income countries. This “drug-lag” causes unnecessary ill-health and death. One way of shortening and making the evaluation and approval process more transparent are product assessments jointly conducted by several national medicine agencies of one region and supported by the World Health Organisation and technical partners such as the Swiss Agency for Therapeutic Products.|
|Objetivos||Improve access to efficacious and safe quality medical products for people in low and middle-income countries, especially in sub-Saharan Africa, through medicines regulatory systems strengthening at the global, regional and country level.|
|Grupos destinarios||Primary beneficiaries are people in African and other low and middle-income countries who are in need of medical products for which marketing authorisation at the level of Swissmedic, WHO pre-qualification programme and national medicine regulatory authorities in Africa is sought. Secondary beneficiaries are national medicine regulatory authorities 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 medical product candidates are also secondary beneficiaries.|
|Efectos a medio plazo||
Outcome 1: Quality and speed of evaluation and registration procedures of jointly assessed medical products in low and middle-income countries has increased at regional and country level
Outcome 2: Number of jointly assessed medical products that are also registered at national level has increased.
Output 1: Harmonized technical guidelines, standards and procedures are established, regularly updated and implemented at regional and country level by 2020 (EAC, ECOWAS, IGAD, OCEAC).
Output 2: Medical product dossiers submitted through regional procedure are jointly assessed by NMRAs in a region according to harmonised guidelines and established standards and procedures.
Output 3: Manufacturing site inspections of pharmaceutical companies selling their products in the respective regional economic communities are jointly conducted by NMRAs in a region according to harmonised guidelines and established standards and procedures.
Output 4: Capacities of regulatory staff from African NMRAs and regional networks strengthened through acquired appropriate knowledge and skills
Output: 5: Technical support provided by different partners to national medicines regulatory authorities or regional regulatory networks is efficiently coordinated by WHO through the Coalition of Interested Partners (CIP).
Output 6: Swissmedic marketing authorisation and scientific advice procedure for medical products against diseases disproportionately affecting people in low and middle-income countries is used by relevant applicants (e.g. Product Development Partnerships; pharmaceutical companies).
Resultados de las fases anteriores:
|Dirección / Officina Federal responsable||
Cooperación al desarrollo
|Contrapartes del proyecto||
Contraparte del contrato
Organización de las Naciones Unidas (ONU)
Swiss Agency for Therapeutic Products (Swissmedic), Bill and Melinda Gates Foundation, Agency for New Partnership for Africa’s Development, African Regional Economic Communities
|Coordinación con otros proyectos y actores||Drugs for Neglected Diseases Initiative, Medicines for Malaria Venture, Foundation for New Innovative Diagnostics, Medicines Patent Pool|
|Presupuesto||Fase en curso Presupuesto suizo CHF 3'542'550 Presupuesto actual suizo ya emitido CHF 944'680|
|Fases del proyecto||Fase 2 01.01.2019 - 31.12.2021 (Fase en curso) Fase 1 01.12.2015 - 31.12.2018 (Completed)|