The annual meeting between the Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, and the German Medicines Manufacturers' Association (Bundesverband der Arzneimittel-Hersteller, BAH) took place on 15 November, 2023. The series of meetings allows for a continuous exchange of information, which is highly appreciated by both sides. Discussion topics included the Paul-Ehrlich-Institut's commitment to support the development of modern vaccines and biomedicines in the European network as well as projects on the applications of artificial intelligence in the Institute's range of tasks. Representatives from the BAH and from its member pharmaceutical companies have been satisfied with the uncomplicated and expertly guided medicines regulation by the Paul-Ehrlich-Institut in Germany and its positive international influence.
"The clinical development of biomedical drugs continues to increase — it is the fastest growing medicinal product group,"
said Professor Stefan Vieths, Vice-President of the Paul-Ehrlich-Institut, at the start of the meeting. He continued, "The Paul-Ehrlich-Institut supports this development with its expertise. The Institute is preparing for the evaluation and batch testing of innovative biological medicines to be expected in the future with its research and a number of projects on the use of artificial intelligence."
The centralised authorisation of medicines in all Member States of the EU or the European Economic Area (EEA) is coordinated by the European Medicines Agency (EMA). The procedures themselves are handled by two national medicines authorities: a rapporteur and a co-rapporteur. Rapporteurs and co-rapporteurs each form an assessment team within their national medicines authority and evaluate the medicinal product candidate independently of each other. They report their results to the Committee for Medicinal Products for Human Use (CHMP), which may make a recommendation for authorisation for the European Commission.
The Paul-Ehrlich-Institut has held a leading position at the EMA for decades in the authorisation assessment procedures as well as in scientific advice and the monitoring of side effects of vaccines and biomedicines. The Institute's position serves to strengthen Germany as a centre for pharmaceuticals.
The number of clinical trials of biomedicines has also been steadily increasing for at least ten years. Modern medicinal product development takes place primarily in the biomedicine field, supported by the Paul-Ehrlich-Institut's unbureaucratic regulatory approach.
The experts exchanged views on topics such as the current status of the Simultaneous National Scientific Advice (SNSA) pilot and electronic user information. The agenda also included the topic of use-specific data collection, which can be demanded by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) as part of the early benefit assessment in accordance with section 35a of Book V of the German Social Code. The pilot project for raw data analysis involves an analysis carried out by experts from the national medicines authorities independent of the applicant. The experts analyse specific medicinal product data submitted with the marketing authorisation application. The project was initiated in July 2022 and was also a subject of this year's meeting.
Another topic of the meeting was the progress made in pilot projects funded by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) on the application of artificial intelligence (AI) in the Paul-Ehrlich-Institut's tasks.
AI is being tested for the pre-assessment of the quality, safety and efficacy of medicinal product candidates as well as for side effect monitoring (pharmacovigilance), for the detection of viruses in blood donations after high-throughput sequencing, and for the evaluation of AI-supported algorithms in tumour immunotherapy.
The representatives of the BAH and its member pharmaceutical companies expressed satisfaction with the uncomplicated and expert-level medicines regulation by the Paul-Ehrlich-Institut in Germany and its positive international influence.
The Paul-Ehrlich-Institut uses the regular dialogue with medicine developers and BAH to continuously develop and optimise its regulatory functions.
Updated: 15.11.2023
