- Palabras clave > harmonization
- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory authority (MRA)
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > regulation
- Palabras clave > regulatory authority - medicines
- Palabras clave > regulatory matters
- Palabras clave > autorités de réglementation pharmaceutique
(2009; 50 pages)
Currently, about 7% of the 46 sub-Saharan African countries have a moderately developed medicine regulatory capacity. Of the remaining, about 63% have minimal capacities whereas 30% do not have a National Medicines Regulatory Authority (NMRA) in place.
Over the years, the World Health Organization together with other international organizations and donor countries has been supporting African countries to establish and strengthen their medicine regulatory authorities. Despite the efforts made however situations have not changed much. Some of the reasons for this have been absence of government support, lack of adequate number of trained and qualified staff, high staff turn-over due to low salaries and lack of incentives, inadequate and unsustainable funding of the NMRAs, weak infrastructure.
A conference of African Medicine Regulators held from 30 October–3 November 2005 in Addis Ababa, Ethiopia discussed the medicine regulatory situation in the subregion and came up with the following as the main characteristics: ineffective licensing system, weak product registration, poor inspection practices, inadequate access to quality control laboratories, inadequate market control, non existence of pharmacovigilance and control of promotion, lack of clinical trials, oversight, inadequate communication and information exchange system, lack of transparency and accountability and conflict of interest.
The result is in many of sub-Saharan African countries medicines are imported into the countries or manufactured locally without any appropriate quality assurance safeguards. In addition, in many of these countries medicines are smuggled across borders and sold in open market places and on streets, leading to a high prevalence of sub-standard and counterfeit medicines. Reports indicate that in sub-Saharan Africa, on the average, as much as 30% of samples of medicines tested fail quality tests.
The meeting also identified inadequate government and public support; law status given to NMRA; inadequate number of qualified and skilled staff; lack of legislation, regulations, guidelines and procedures; inadequate and unsustainable resources; weak enforcement mechanisms and sanctions and corruption to be the main barriers to the improvement of medicine regulation in the subregion...