- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > developing countries
- Palabras clave > harmonization
- Palabras clave > medicines regulatory authority (MRA)
- Palabras clave > premarketing assessment of medicine safety
- Palabras clave > registration
- Palabras clave > regulation
- Palabras clave > regulatory matters
- Palabras clave > regulatory systems
- Palabras clave > supply system
(2004; 16 pages)
The World Health Organization has popularised the approach that access to medicines, whether in developed or developing countries, is reliant on four interlocking factors: rational selection of the medicines to be used, affordable prices for those medicines, sustainable financing of healthcare (including medicines) and reliable health and supply systems. An effective medicines regulatory authority (MRA) is a crucial part of a “reliable health and supply system”.
Medicines registration is the process by which a national or regional MRA approves the use of a medicine in a particular country, having considered evidence of the medicine’s safety, quality and efficacy. It is thus primarily concerned with protecting public health. However, where medicines regulatory processes are unwieldy and delay entry of needed medicines in a particular market, they can be seen as a barrier to access as well as to profits and the growth of the pharmaceutical industry. Premarketing assessment of safety, quality and efficacy is however only one component of a medicines regulatory system. In addition, attention must be paid to ongoing assessment and inspection of the entire pharmaceutical supply chain (including manufacturers, importers, exporters, wholesalers, distributors and final sellers), maintenance of a register of approved products and post-marketing surveillance (including random quality checks and pharmacovigilance systems), control over the promotion and advertising of medicines and the provision of medicines information.
Lastly, there is a view that issues related to the rational pricing of medicines and considerations of cost-effectiveness may also legitimately fall within the ambit of the medicines regulatory agency.