In mid-2016, the new European regulations will come into effect once the European database (the ‘portal’) is ready. From that moment on, the submission process for drug research will be aligned for all EU Member States. The idea is that the new regulation will speed up the filing process and increase the number of drug trials in Europe. It will also reduce the administrative burden, costs and time between an application and the start of an investigation.
The regulation will replace the existing Directive 2001/20 / EC and will apply directly to all EU Member States upon entry into force. So we do not have to wait for implementation in local laws.
Cooperation in cross-border investigations necessary
There are many pros and cons to think about. The intention is for the new regulation to ensure greater harmonization and cooperation between several Member States in the field of
cross-border drug research. And that is necessary – if we want Europe to remain interesting for drug manufacturers and compete with the United States, Asia and emerging regions. In order to continue clinical research in Europe, we must ensure that manufacturers do not divert to regions where the approval process is shorter or better regulated.
During the FIGON days the practical implications were discussed and discussed. How, for example, are we going to do the implementation process in the Netherlands? Should we overturn the entire Dutch rating system? What implications will that have? Harrie Storms, senior policy officer Ethics at the Ministry of Health, Welfare and Sport, took us through the bill.
- For drug research that takes place within our national borders, little changes are made to the assessment procedure – whether it issingle or multicenterresearch. The only change is that the submission now goes via the EU portal.
- Especially for multinational drug studies, a lot of changes are going on in the assessment process. The process consists of two parts: central and national. There is a central assessment by a chosen reporting Member State. They look at the most critical aspects of the study, such as risks and inconveniences, relevance, reliability data and the production of the medicine.
- Other local aspects, such as patient information, insurance and the suitability of researcher and research institute, are tested in parallel by the member states where the research is being conducted. They do not therefore assess the critical aspects, but can give input to the reporting Member State within a certain period of time..
What does this mean for the Netherlands? There are several implementation models possible, and clarity about that is not yet available.
Ready for change
One thing is certain, clinical Netherlands must be ready for change. We can take this opportunity, for example, to adjust our sometimes cumbersome system. At GCP Central we ensure that we can move with the market, by following these developments closely and translating its relevance for doctors, researchers and other research professionals into pragmatic learning tools. The European regulation is explained in our current GCP training and can be found in the library of the learning environment.
Read more about the regulation on the CCMO website or follow our GCP course to get back up to date.