On 12 June, 2024, experts from the Paul-Ehrlich-Institut and representatives from the Association of Research-Based Pharmaceutical Companies (Verband forschender Arzneimittelhersteller, vfa) met for their annual exchange. Agenda topics included the possibilities for gaining more flexibility within authorisation procedures in connection with the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS). The experts also discussed changes to the interfaces of EU medicinal product legislation and to the EU Regulations on In Vitro Diagnostics (IVDR) and Medical Devices (MDR) and other central medicinal product safety and authorisation topics.
The acting President of the Paul-Ehrlich-Institut, Professor Stefan Vieths, kicked off the discussion between regulatory experts by giving an overview of the Paul-Ehrlich-Institut's ongoing reorganisation, which is creating the structural conditions for even more agile responses to current challenges. He also reported on the Paul-Ehrlich-Institut's authorisation and consultancy services as well as its development of federal batch testing and release procedures. Representatives from the vfa explained the industry importance of the Medical Research Act (Medizinforschungsgesetz, MFG). Professor Vieths reported on the implementation of central measures within the framework of the MFG being carried out in cooperation with the Federal Institute for Drugs and Medical Devices (BfArM). BfArM Vice President Professor Knöss was also present at the meeting and reaffirmed the cooperation. The acting director of the Center for Pandemic Vaccines and Therapeutics (ZEPAI), Dr Joachim Bug, presented the ZEPAI's legal mandate, committee work, and fields of action between pandemics.
The experts were engaged in particularly extensive discussions regarding the current state of clinical trial regulation and the EU In Vitro Diagnostic Regulation. The CTR was made binding at the beginning of 2022 and sets strict deadlines for authorisation procedures. There was a resulting need to discuss the potential for developing pragmatic solutions for more flexibility in authorisation procedures within the CTR and CTIS. The attendees also discussed the additional requirements for certain performance studies laid down in the IVDR. Additionally, the agenda included topics such as the publication of commissioned training materials on active substances and medicinal products and pharmacovigilance inspections and digitalisation. Examples of the latter include the implementation of electronic product information (ePI) and the purely digital distribution of direct healthcare professional communications.
The annual meeting with the vfa is an established dialogue platform. The constructive exchange of experience and information shows how important continuous knowledge sharing between regulatory authorities and the pharmaceutical industry is for the quality, effectiveness, and availability of medicinal products in Germany and Europe.
Updated: 13.06.2024
