Regulation of Biomedicines: Paul-Ehrlich-Institut in Discussion with the German Pharmaceutical Industry Association BPI

Reg­u­la­tion of Biomedicines: Paul-Ehrlich-In­sti­tut in Dis­cus­sion with the Ger­man Pharma­ceutical In­dus­try As­so­ci­a­tion BPI

In the European Economic Area (EEA), biomedicinal products are generally authorised by the European Commission in all member states as part of centralised approval procedures. The European Medicines Agency (EMA) coordinates these procedures, in which the benefit-risk assessment is carried out by experts from the national medicines authorities. At the association meeting with the BPI, the acting President of the Paul-Ehrlich-Institut, Professor Stefan Vieths, reported on the experience of adopting centralised procedures for vaccines and biomedicinal products.

The clinical trials of medicinal products are approved by the national medicines authority of the EU member state in which they are to take place. Professor Vieths reported that a total of 805 applications for clinical trials were submitted in Germany in 2023 (previous year: 985 applications). In the area of vaccines and biomedicines, 310 applications for clinical trials were submitted. The discussion also covered the EU and Germany in general as a trial location and the possibility of speeding up clinical trial procedures. The participants also discussed their experiences in connection with the new Clinical Trial Regulation (CTR).

Another topic of the meeting was the SoHO legislation, which is due to come into force by June 2024 after final approval by the Council and European Parliament. Its aim is to ensure the supply of blood plasma products and improve self-sufficiency across Europe. Other topics discussed at this year's meeting included the Institute's ongoing KIMERBA project in the field of artificial intelligence, the German Haemophilia Registry (DHR) and the marketing authorisation of therapeutic allergens.

The regular meetings with the BPI and other associations provide a platform for discussing general and specific issues relating to clinical trials, marketing authorisations, approvals, follow-up procedures and other regulatory aspects and for exchanging experiences.