On 17 March 2023, experts from the Paul-Ehrlich-Institut came together for a discussion with representatives of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI) and of the pharmaceutical manufacturers and developers within the BPI. The Paul-Ehrlich-Institut has been holding annual meetings with the BPI and other associations since 2010. The regular and open dialogue that results from these meetings is an important prerequisite for the common goals of providing safe and effective medicines and driving innovation. The topics of this year's meeting, in addition to the activities of the Paul-Ehrlich-Institut in centralised authorisation procedures and approvals of clinical trials, included the second phase of the multinational scientific advice pilot project and support from medicines authorities for the development of advanced therapy medicinal products (ATMPs).
In all Member States of the European Economic Area (EEA), biomedicines are generally authorised by the European Commission for all Member States under centralised authorisation procedures. The European Medicines Agency (EMA) coordinates the procedures, during which the benefit-risk assessment is carried out by experts from the national medicines authorities. The President of the Paul-Ehrlich-Institut, Professor Klaus Cichutek, reported at the BPI meeting on the Paul-Ehrlich-Institut's ten plus years of leadership in the takeover of centralised procedures of vaccines and biomedicines. In addition to procedures regarding ATMPs and vaccines, the Institute often assumes the role of (co-)rapporteur on the European Committee for Human Medicinal Products (CHMP), primarily when antibodies are involved.
Clinical trials of medicines are approved by the national medicines authority of the EU Member State where they are to take place. The Institute President reported that a total of 401 clinical trial applications for vaccines and biomedicines were submitted in Germany in 2022. This corresponds to more than 40 percent of all clinical trials in Germany. The number of applications for clinical trials for vaccines and biomedicines has therefore almost doubled over the past 15 years. Part of the discussion was also focussed on experiences with the hitherto not so user-friendly nor time-saving Clinical Trials Information System (CTIS), through which all applications for clinical trials in the European Economic Area (EEA) must be centrally submitted as of January 2023.
Another topic of the association meeting was the launch of phase 2 of the Simultaneous National Scientific Advice (SNSA) project. This procedure allows drug developers to obtain scientific advice from up to three medicines authorities in different EU Member States at the same time. Phase 2 of the pilot project is expected to run until the end of 2024. The aim is to provide scientific and regulatory advice from multiple national medicines authorities in one procedure, e.g. for applicants seeking to conduct a clinical trial in several Member States. Institute President Cichutek also reported on the Paul-Ehrlich-Institut's initiatives to support the development of drugs for novel therapies, such as the international ATMP workshop on scientific and regulatory aspects, which was organised last year by the Paul-Ehrlich-Institut and took place in Langen.
"The regular meetings with the BPI and other associations provide a platform to discuss and exchange experiences on specific questions regarding clinical trials, marketing authorisations, follow-up procedures and other regulatory aspects. They are thus an essential basis for the Paul-Ehrlich-Institut's services in regards to providing support and regulatory monitoring throughout the entire drug development lifecycle,"
emphasised Cichutek. Other topics of this year's meeting included ongoing Institute projects in the field of artificial intelligence, the supply situation for blood and plasma products, as well as the authorisation of therapeutic allergens.
Updated: 22.03.2023
