The authorisation of medicinal products and the framework within which this takes place in Europe is unique in the world. All European Member States have their own experience, medical culture and expertise. The registration authorities have built a network in order to combine these factors wherever possible. They receive cooperation and support from the European Medicines Agency (EMA). Thanks to this network, the national authorisation agencies are able to divide the workload and make use of each other’s expertise.
Pharmacovigilance Risk Assessment Committee (PRAC)
The PRAC (Pharmacovigilance Risk Assessment Committee) plays a key role in the supervision of the risks of human medicinal products in Europe. The PRAC holds monthly meetings at the European Medicines Agency (EMA). The PRAC sends recommendations to the Committee for Medicinal Products for Human Use (CHMP) and the European decision-making body CMDh about the risks of medicinal products authorised in the European Union. Dr Sabine Straus (The Netherlands) chairs the PRAC. Dr. Menno van der Elst is the representative for the Netherlands on the PRAC; Dr Liana Gross-Martirosyan is the alternate member.
Decision-making body (CMDh/CMDv)
The CMDh (Co-ordination group for Mutual recognition and Decentralised procedures human) is a European decision-making body responsible for the proper functioning of the Mutual Recognition and Decentralised Procedures in the assessment of medicinal products for humans. The CMDv (Co-ordination group for Mutual recognition and Decentralised procedures veterinary) is the European decision-making body for animals. Ms Kora Doorduyn is a member of the CMDh; Ms Priscilla Schoondermark is the alternate member. Ms Trudy Knol is a member of the CMDv.
Committee for Medicinal Products for Human Use (CHMP)
In the case of centralised procedures, medicinal products are assessed by the European scientific committee (Committee for Medicinal Products for Human Use - CHMP). Within this committee, the reporter and co-reporter coordinate the expertise present at a national level for a European assessment. The EMA primarily plays a supporting role. Prof. Hans Hillege is a member of the CHMP on behalf of the Netherlands; Dr Paula van Hennik is the alternate member.
Committee for Orphan Medicinal Products (COMP)
The Committee for Orphan Medicinal Products (COMP) works in a comparable manner. Each country has one representative on this committee and together with a coordinator from the EMA they are responsible for the assessment of a possible status as an orphan medicinal product for a specific product. Dr Violeta Stoyanova (The Netherlands) chairs the COMP.
Scientific Advice Working Party (SAWP)
There is also a Scientific Advice Working Party (SAWP), which has opted to elect the members based on their expertise. This means that the 27 EU Member States are not all represented. Dr Hans Ovelgönne and Dr Peter Mol are members on behalf of the Netherlands.
Quality & Safety Working Party
Nobody has all the required expertise in-house and very few authorisation agencies are able to supply the highly skilled knowledge required for all problems immediately. However, the European network guarantees that the knowledge that is present can be combined and that each member state can offer input. The Netherlands plays an important role in Europe through active participation in the network and participation in many groups. Among other committees, the Netherlands is represented on the Quality Working Party and the Safety Working Party.