BIO Deutschland’s Working Group on Regulatory Matters Meets in Munich

At the beginning of June, BIO Deutschland’s Working Group on Regulatory Matters met in Munich to discuss current developments in legal requirements in the field of medicinal product licensing. The topics on the agenda were medicinal products for advanced therapies, the revision of the Clinical Trials Directive, and orphan drugs.

Advanced therapy medicinal products (ATMPs) are currently being intensively discussed on the European level. The aim of the ATMP regulation was to improve and simplify matters for ATMP manufacturers by introducing a centralised licensing procedure with subsequent EU marketing authorisation. However, the reality looks different – so far, only one product has been licensed for the entire EU. The ATMP committee specially set up by the European Medicines Agency (EMA) is “unemployed” and many manufactures have to take/will take their products off the market after the transition period expires at the end of the year due to the lack of centralised licensing. The working group experts want to prevent this and have therefore started talks with the responsible European authorities. The aim is to maintain the marketability of existing ATMPs and to make authorisation much more straightforward. This should be of particular help to small and medium-sized companies active in this field in launching their products on the market.

The European Commission is currently revising the Clinical Trials Directive. An EU consultation on this topic from early 2011 states that the Commission is starting to think about a centralised licensing procedure for all clinical trials conducted in more than one country. In addition, the directive is to be changed into a regulation. This means that it would not have to be transposed into national law in the individual EU member states, but would apply automatically. A first draft is expected before the summer recess. The experts will remain involved in the further work process in terms of contents.

Aldo Ammendolavon (4SC AG) reported on his experiences in the development of orphan drugs. He gave advice and ideas for developing and applying for an orphan drug label.

The minutes of the meeting will shortly be available to BIO Deutschland members from the association’s office (Tel.: +49 (0)30-3450593-30, e-mail:

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