Meeting of the Working Group on Regulatory Matters

BIO Deutschland’s Working Group on Regulatory Matters used BIOTECHNICA in Hanover as an opportunity to hold a meeting. Following a short presentation on the paediatric test plan and its regulatory requirements, the experts discussed the effects of the Paediatric Regulation.

There was a detailed discussion on the European initiatives to publish preclinical and clinical data. In addition to the amendments made to the proposal for a regulation on clinical trials on medicinal products for human use (draft Clinical Trials Directive), the European Medicines Agency (EMA) has presented a guideline to the consultation in favour of active publication. The working group’s experts regard both initiatives as obstructive. BIO Deutschland has submitted a statement to the EMA and sought dialogue at the European level with the aim of preventing the misuse of published data. The working group expressly welcomes research institutes’ access to clinical data for research on and development of new medicinal products. However, it believes that the EU should wait until court rulings have been issued in the cases of InterMune v. EMA and AbbVie v. EMA before creating irreversible conditions by redrafting the legal framework. After this meeting, the working group held a joint meeting on companion diagnostics with the Working Group on Diagnostics. BIO Deutschland members are welcome to request a copy of the minutes of the meeting from the association’s office (e-mail: info@biodeutschland.org).