Scientific Advice by PEI and CHMP
What is scientific advice, how is it conducted, and what is expected from the applicant?
These important questions were at the heart of last week’s EKFZ Academy workshop. Dr. Jens Reinhardt, a regulatory scientist at the Paul-Ehrlich-Institut (PEI) and a member of the Scientific Advice Working Party of the European Medicines Agency (EMA), presented the advisory options of the higher-level regulatory authorities in Germany and the EMA’s Scientific Advice Working Party. He explained the responsibilities and procedures of the authorities and provided examples of correct and incorrect approaches to advice. Through early exchange with the competent authorities in the development process, scientists and physicians learn more about the quality and safety requirements for medicinal products, thus contributing to the successful market authorization of their products.
The key takeaways were:
– The Paul-Ehrlich-Institut offers tailored scientific advice on regulatory requirements throughout the entire drug development phase – from active substance discovery to market authorization and beyond.
– Scientific advice from the Paul-Ehrlich-Institut or the EMA is not legally binding for the regulatory authorities or the drug developer.
– Scientific advice is forward-looking and answers specific questions from the applicant regarding concepts and regulatory aspects of drug development with a view to clinical trials and market authorization.
We sincerely thank Dr. Jens Reinhardt for his profound and valuable expertise!
