European Medicines Agency and World Health Organization
Working for product safety in the developing world
The European Medicines Agency (EMEA) is the regulatory body for the European Union. The agency evaluates and supervises medicines for use in the European market, playing a function similar to that of the Food and Drug Administration in the United States. The EMEA recently established a mechanism, called Article 58, allowing it to give a scientific opinion for the evaluation of vaccines and drugs for human use intended exclusively for markets outside the European Union.
The EMEA conducts this function in close cooperation with the World Health Organization (WHO), which helps to streamline and accelerate the WHO prequalification process. Though the EMEA procedure does not take the place of all aspects of regulatory capacity—such as monitoring use, sustained manufacturing, and labeling— it provides a level of confidence that a product is safe and effective.
Improving access to needed medicines
WHO’s Prequalification Programme was established to improve access to medicines and vaccines that meet unified standards of quality, safety, and efficacy. Initially, the process was set up to provide United Nations procurement agencies with high-quality medicines. It has since become useful for entities that purchases medicines in bulk, including developing countries. The process is not intended to replace national regulatory authorities, but it is an important step in enhancing access to medicines for the developing world.
For more information on the above data, see:
European Medicines Agency (EMEA).
World Health Organization (WHO).
European Medicines Agency, Opinions on medicines for use outside the European Union.
