The Working Group on Regulatory Affairs Submits Suggestions on Advanced Cell Therapies to the Federal Ministry of Health and the European Parliament and Gives a Statement on the Assessment Report by the Paul Ehrlich Institute for Licensed Medication

Under the management of Professor Felicia Rosenthal, BIO Deutschland submitted suggestions on the EU draft regulations on advanced cell therapies to the Federal Ministry of Health in January 2007. The association expressed its views on the following points:

• The definition of so-called “advanced therapy medicinal products”
• Incentives for small and medium-sized biotech companies
• Keeping a national licensing office for advanced therapy medicinal products
• Supporting a Europe-wide central licensing office for advanced therapy medicinal products
• Exceptions for hospitals and clinics

BIO Germany’s statement will also be contributed to the European Parliament’s talks in the near future.

Furthermore, the working group submitted comments on an extract from the draft of the standard information on the “Drafting of Assessment Reports and Public Information on Licensed Medication According to the Drug Law and the Animal Epidemic Law/Animal Vaccination Regulation” to the Paul Ehrlich Institute as the organisation responsible for these matters. The suggested procedure met with the general approval of the association.