The authorisation of medicines and the framework within which that takes place in Europe, are unique in the world. All European member states have their own experience, medical culture and expertise and the registration authorities have created a network to bring this all together. They have done so with the cooperation and support of the EMA, the European Medicines Agency. Thanks to this network, national regulatory authorities can share work and make optimal use of each other's expertise.
The Pharmacovigilance Risk Assessment Committee (PRAC)
The Pharmacovigilance Risk Assessment Committee (PRAC) plays an important role in terms of supervising the risks of medicines for people in Europe. The PRAC meets on a monthly basis at the European Medicines Agency (EMA). The PRAC makes recommendations to the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) about the risks of medicines which are authorised in the European Union.
Decision-making body (CMDh/CMDv)
The European decision-making body for people is the Coordination group for Mutual recognition and Decentralised procedures – human (CMDh). It is responsible for the proper functioning of the Mutual Recognition and Decentralised Procedures for the assessment of medicines for human use. The Coordination Group for Mutual recognition and Decentralised procedures - veterinary (CMDv) is the European decision-making body for veterinary medicines.
The Committee for Medicinal Products for Human Use (CHMP)
In the case of centralised procedures, medicines are assessed by the CHMP (the Committee for Medicinal Products for Human Use). In the CHMP two rapporteurs are appointed for each medicine who follow the product throughout its entire life cycle. In this context the EMA primarily plays a supporting role. The CHMP advises the European Commission with regard to definitive decision-making. The resulting marketing authorisation then applies to all EU member states.
The most important points for discussion by the CHMP are:
- Recommendations regarding new marketing authorisations
- Indication extensions in relation to (centrally registered) medicines
- Reassessments as a result of safety or quality issues in conjunction with (centrally registered) medicines.
New medicines in the field of cancer, AIDS, neurodegenerative illnesses, diabetes and biological medicines are always subject to a centralised procedure via the CHMP.
The Committee for orphan medicinal products (COMP)
The Committee for Orphan Medicinal Products (COMP) works in a similar way. Every country has a representative in that group who is responsible, together with a coordinator from the EMA, for assessing a possible status as orphan medicine.
Scientific Advice Working Party (SAWP)
In addition, there is the Scientific Advice Working Party (SAWP), whose members are selected on the basis of expertise. Consequently, not all 27 EU countries are represented.
Quality & Safety Working Party
No one has all the necessary expertise, and only few authorisation authorities can directly provide highly qualified people with the necessary knowledge, for all problems. However, the European network guarantees that the existing knowledge will be combined and that each member state will be able to contribute. The Netherlands is playing an important role in Europe by being active in the network and contributing positively to numerous groups. For example it is represented in the Quality Working Party and the Safety Working Party.