1. Medicines regulation - ensuring effective medicines with acceptable risk

Medicines regulation demands the application of sound medical, scientific and technical knowledge and skills, and operates within a legal framework. Regulatory activities involve interactions with various stakeholders (e.g., pharmaceutical industry, traders, consumers, health professionals, researchers and governments) whose economic, social and political motives may differ, making implementation of regulation both politically and technically challenging.

Medicines regulation has an administrative part but far more important is the scientific basis for it. Thus, Governments need to establish strong regulatory authorities (on the national level called National Competent Authorities, NCAs), to ensure that the development, manufacture, trade and use of medicines are regulated effectively.

As already mentioned, all medicines must meet the three criteria of quality, safety and efficacy, and the judgments about these should be based on solid science. There are several general and specific factors contributing to effective regulation by a regulatory authority. They include a clear mission statement, adequate medicines legislation and regulation, appropriate organisational structure and facilities, clearly defined roles and responsibilities, adequate and sustainable financial resources, and appropriate tools, such as standards, guidelines and procedures and internal collaboration with all stakeholders, transparency (making transparent how and based on which information decisions are made) and accountability combined with good management and effective internal quality systems. Minimum functions that a regulatory authority should be able to carry out are laid down in the following:

A regulatory authority should

• Ensure that all medicines manufacturing, importation, exportation, wholesale and distribution establishments are licensed. Activities and premises must comply with Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP) requirements

• Before medicines are marketed, assess their quality, safety and efficacy

• Monitor the quality and safety of medicines on the market to prevent harmful, substandard and counterfeit medicines from reaching the public and to adapt the MA and package leaflet if needed (see also “Pharmacovigilance”).

• Regularly inspect and control the informal market, including e-commerce, to prevent illegal trade of medicines

• Monitor advertising and promotion of medicines, and provide independent information on their rational use to the public and professionals

• Participate in sub-regional and regional regulatory networks and international meetings of drug regulatory authorities to discuss issues of mutual interest and concern, facilitate timely exchange of information and promote collaboration

• Monitor and evaluate performance to assess if perceived regulatory objectives have been met, to identify weaknesses and take corrective action

Source: WHO Policy Perspectives on Medicines no 7, 2003.