The regulation of drug circulation is at the heart of ensuring that only high-quality drugs are allowed on the market. Drugs must be effective in treating the target disease or condition. These drugs must not cause unacceptable side effects and must be of high quality.

In Europe, the European Commission proposes high-level legislation in the form of regulations and directives. Proposals are approved and become legislation with the cooperation of the Commission, EU member states represented by the Council of Europe (CoE), CoE working groups and the European Parliament. Individual EU member states are represented in this process by the CoE working groups.

Detailed instructions on the best or most appropriate way to comply with the obligations under EU pharmaceutical law are provided in the form of recommendations. They contain explanations for registrants or registrant holders, competent authorities and/or other interested parties. The guidelines are developed by the European Medicines Agency (EMA, European Medicines Agency) or the European Commission. The EU also cooperates with other countries to prepare harmonised guidelines, e.g. USA, Japan, Canada, Switzerland and other countries participating in the International Council on Harmonisation (ICH) as well as the World Health Organisation (WHO). At the annual meetings of the WHO and the European Commission leadership members common problems in the field of drug circulation are discussed. The results of all these meetings and joint work influence the EU legislation.

WHO and the EMA also cooperate in developing common regulatory capacity. In addition, the EMA can assist WHO in assessing the challenges in the circulation of medicines intended for markets in other countries outside the EU.

The European Medicines Regulatory Network
National competent authorities (national regulatory authorities) cooperate with the EMA to form specific and detailed guidelines for the industry. An informal network has been established between the heads of the drug agencies of each EU member state. This network has regular meetings with EMA representatives.

National competent authorities are involved in the process of drug legislation at all levels. Officially, the Ministry of Health of the EU Member State is involved in the process of drafting directives and regulations, often through a member of the staff of the national competent authority. The EMA coordinates the process of developing and revising the EU scientific guidelines. This work is carried out by EMA working groups/parties. As a rule, the national competent authorities of each Member State appoint a representative to each EMA working group, which carries out most of the work of developing the scientific recommendations.

Regulatory recommendations are most often developed by the European Commission’s Explanatory Notes working group for applicants. Representatives of national competent authorities are also substantially involved in the process in this group.

Development of guidelines in the EU
The development of scientific recommendations on the circulation of medicinal products follows an established procedure, which is generally applied by all working groups of the EMA Committee for Medicinal Products for Human Use (CNMP, Committee for Medicinal Products for Human Use):

A concept paper on the new recommendation.
Adoption by the CNMR committee.
Appointment of a rapporteur.
Draft recommendation in working group.
Draft published for concurrence.
Comments.
Finalization of the recommendation by the working group.
Adoption of the recommendation by the CHMP committee.
Putting the recommendation into effect.

Members of the working groups are appointed by the national competent authorities of the EU member states from their staff. The proposal to develop this new recommendation must be approved by the CHMP committee before the working group begins developing the recommendation.