Di­a­logue: Ger­man As­so­ci­a­tion of Pharma­ceutical Man­u­fac­tur­ers (BAH) Vir­tu­al Guest at the Paul-Ehrlich-In­sti­tut

"The Paul-Ehrlich-Institut is actively involved in the fight against the pandemic. With our scientific expertise, we support the rapid, centralised authorisation of monoclonal antibodies and vaccines for the treatment and prevention of COVID-19 through drug evaluation, batch testing, pharmacovigilance and inspections, especially in times of pandemic," emphasised Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, at the start of the meeting. The Paul-Ehrlich-Institut is an internationally networked and recognised player. As part of the European Official Medicines Control Laboratory (OMCL) network, the Institute experimentally tests batches of COVID-19 vaccines using innovative test methods. Its research contributes to the basic understanding of the mechanisms underlying drug efficacy and safety.

The tasks of the Paul-Ehrlich-Institut, which provides regulatory support for the entire development process of vaccines and biomedical drugs from discovery to authorisation and beyond, also include a range of target-group-specific advisory formats for academic research institutes and university hospitals as well as for developing and manufacturing companies.  The offer – coordinated by the Paul-Ehrlich-Institut’s Innovation Office – conveys the regulatory and scientific requirements in the various phases of drug development. In dialogue with the BAH, further optimisations and the further development of the advisory service were initiated.

The development of biomedicines moved into focus with the onset of the pandemic. While 309 applications for clinical trials were received at the Paul- Ehrlich-Institut in 2019, the number jumped to 390 in the first pandemic year 2020. To enable further European harmonisation, the Paul-Ehrlich-Institut proposed a pilot project to the Heads of Medicines Agencies (HMA) in which two medicines authorities from different EU Member States selected by the applicant jointly provide scientific advice (Simultaneous National Scientific Advice, SNSA), which has been successfully continued.

Biomedicines cannot be produced as generics even after the patent has expired, as their structure and mode of action are too complex for evaluation within the framework of simple generic drug procedures. Therefore, similar biomedicines, the biosimilars, are developed which are highly similar to a reference medicinal product (originator product) authorised in the EU and have the same effect. The authorisation of biosimilars is carried out centrally by the European Commission. Since October 2021, an optimised regulatory process has been available for the testing of biosimilars. The Paul-Ehrlich-Institut contributes its expertise to the HMA's Biosimilar Group, which has been in existence since September 2021. The Institute's scientific opinions are internationally sought after and valued.

The assertion of the Paul-Ehrlich-Institut's leading position in the adoption of procedures on vaccines and biomedical medicinal products in the committees of the European Medicines Agency (EMA) is, in the BAH's view, an important locational advantage for Germany. Other topics discussed included the flow of information between the Paul-Ehrlich-Institut and the Federal Joint Committee (G-BA), preparation for the new EU harmonised procedures for the approval of clinical trials next year and the fight against counterfeit medicines.

The tasks of the newly established pandemic centre ZEPAI at the Paul-Ehrlich- Institut were explained and the BAH and its associated drug developers offered their cooperation with the centre. In future, ZEPAI will ensure the rapid provision of pandemic vaccines and therapeutics.

Proven offers and newly established processes for optimising regulatory cooperation will be continuously developed and optimised in regular dialogue with the BAH. This successful path was also continued at this meeting.