- Palabras clave > African Medicines Agency (AMA)
- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > harmonization of medicines regulation
- Palabras clave > International Coalition of Medicines Regulatory Authorities (ICMRA)
- Palabras clave > medicines registration systems
- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory authority (MRA)
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > regulatory authority - medicines
- Palabras clave > regulatory harmonization
- Palabras clave > autorités de réglementation pharmaceutique
(2014; 8 pages)
Effective medicines regulation promotes and protects public health. Regulation aims to ensure the quality, safety and efficacy of medical products through the enforcement of legislation, norms and standards. National Medicines Regulatory Authorities (NMRAs) with adequate capacity including a clear legal mandate, quality management systems, human and financial resources, infrastructure and enforcement systems can efficiently play this role of medicines regulation. However, the regulatory systems in many countries are weak, delaying access to quality medical products and resulting in the proliferation of substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.
To prevent the circulation and use of SSFFC medical products, the Sixtieth Session of the WHO Regional Committee for Africa, held in Malabo, in 2010, stressed the need to strengthen the capacities of NMRAs and, to that end, recommended the establishment of an African Medicines Agency (AMA)...
Globally, there is only one example of a regional centralized regulatory system, i.e. the European Medicines Agency (EMA). The European Union (EU) harmonization, which began in 1965, started with the creation of Community-wide mechanisms and a clear definition of the mandate of the Community and the mandate of Member States...