On 29 November 2022, the Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, continued its active dialogue with the German Medicines Manufacturers Association (Bundesverband der Arzneimittel-Hersteller, BAH). One of the topics discussed was innovative biomedicines, which are urgently needed to combat diseases such as cancer or autoimmune diseases. The Paul-Ehrlich-Institut provides support for the clinical development of these drugs from the outset. Beginning in the run-up to clinical trials, the Paul-Ehrlich-Institut creates a regulatory baseline by offering advisory services, scientific exchange and dialogues with pharmaceutical associations. As a result, promising innovative therapies can be converted into clinical trials in a structured manner. A look to the future shows that artificial intelligence (AI) could further optimise the regulation of biomedicines. The Paul-Ehrlich-Institut seeks to prioritise the future possibilities of AI with its projects.
“The clinical development of biomedicines is becoming increasingly relevant,” said Prof Klaus Cichutek, President of the Paul-Ehrlich-Institut, as the meeting began. "The Paul-Ehrlich-Institut supports that trajectory by contributing its expertise to areas such as the new concept of multinational consultations."
The “Simultaneous National Scientific Advice” (SNSA) process, which will enter phase 2 in 2023, will allow developers to seek joint advice from the national pharmaceutical authorities of three EU Member States, one of which will participate as an “observer”. This makes it easier to apply for multi-centre clinical trials conducted in several EU Member States. The advantages of this new advisory service were discussed in dialogue with the BAH.
The Paul-Ehrlich-Institut has continuously expanded its specialised expertise in highly innovative Advanced Therapy Medicinal Products (ATMPs), such as edited and mRNA-based gene therapeutics. The Institute's ATMP competency was reflected in its organisation of the international ATMP workshop on scientific and regulatory aspects of innovative gene therapeutics, held on 27 September 2022. The objectives of the workshop were to create a dialogue between developers and regulators and to provide information on scientific and regulatory requirements with regard to clinical trials.
AI applications will become increasingly important for the development of medicines and vaccines. AI is used for pattern recognition and analysis of large amounts of data (Big Data). The Paul-Ehrlich-Institut's AI projects improve its testing of AI-based algorithms in clinical trial applications and marketing authorisation processes. After regulatory data is digitalised, research will also be carried out on how AI can be used for consistent data verification. Other ongoing projects at the Paul-Ehrlich-Institut that are funded by the Federal Ministry of Health (BMG) are intended to further develop the Institute's "omics" method repertoire and AI-based data analysis (whole-genome analysis), as these methods play an increasingly important role as the basis for biomedical developments.
Applications for the approval of a clinical trial must be submitted via the CTIS (Clinical Trials Information System) portal in accordance with European Regulation EC No. 536/2014 (Clinical Trial Regulation; CTR). Applicants should inform the Paul-Ehrlich-Institut in advance if they wish to indicate the Institute as a reporting Member State (rMS).
In order to continue to obtain simultaneous approvals of clinical trials for medicinal products containing genetically modified organism (GMOs) and the necessary release approval in Germany, applicants must submit an application for release approval to the Paul-Ehrlich-Institut via the Common European Submission Portal (CESP) in parallel to the CTIS portal application for approval of the associated clinical trial. Standardised applications (Common Application Forms; CAFs) are available for the application for release approval, which, in addition to the Paul-Ehrlich-Institut, are accepted by the competent authorities of most EU Member States and Norway.
Following the outbreak of monkey pox in 2022, the possibility of the viruses being transmitted via blood products was discussed. So far, however, a transmission of the MPX virus via blood has not been observed. The Paul-Ehrlich-Institut therefore sees no reason to change the requirements for donor exclusion criteria for blood donors that meet sufficient blood safety levels.
For at least a decade, the Paul-Ehrlich-Institut has been at the forefront in the adoption of procedures for vaccines and biomedicines on the committees of the European Medicines Agency (EMA). The BAH reaffirmed that this position provides a significant advantage to Germany.
Regular dialogue with the BAH and drug developers allows the Paul-Ehrlich-Institut to continuously develop and optimise its regulatory tasks.
Updated: 02.12.2022
