Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

For the Progress of Biomedicines: Paul-Ehrlich-In­sti­tut in Dis­cus­sion with the Ger­man Pharma­ceutical In­dus­try As­so­ci­a­tion (BPI)

On 2 March 2022, experts from the Paul-Ehrlich-Institut met via video conference with representatives from the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI) and with drug manufacturers and developers organised within the BPI. "Regular and open dialogue with the German Pharmaceutical Industry Association is an important prerequisite for our common goal of providing safe and innovative medicines for the people of Germany and the healthcare system," stated Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut. The still highly topical Coronavirus pandemic and the activities of the Paul-Ehrlich-Institut relating to the protection of public health during the pandemic were among the topics of this year's meeting. Other talking points included the extension of the simultaneous national scientific advice pilot project (SNSA), which has been running since February 2020, blood and plasma products, the German Haemophilia Registry (Deutsches Hämophilieregister, DHR), allergy therapeutics, and clinical research. Practical aspects such as electronic product information and its application were also discussed.

Online Meeting (Source: Andrey Popov/Shutterstock.com)

Innovative biomedicines in Europe are authorised by the European Commission within the standard framework of centralised authorisation procedures. These authorisations apply in all member states of the European Economic Area (EEA). The European Medicines Agency (EMA) coordinates the procedures, during which experts from the national medicines authorities and agencies carry out the EMA benefit-risk assessment. The President of the Paul-Ehrlich-Institut, Professor Klaus Cichutek, reported on the centralised procedures for medicines under the responsibility of the Paul-Ehrlich-Institut that occurred between 2016 and 2021. "During this timeframe, the Paul-Ehrlich-Institut took on 71 of a total of 233 procedures in the area of biomedicines as rapporteur or co-rapporteur. In doing so, the Institute has taken a leading role in the authorisation of biomedicines for Europe," said Cichutek.

Clinical trials of medicines are approved by the medicines authority of the EU Member State where they are to take place. One topic of the meeting was the extension of the SNSA project: EU drug developers will still have the opportunity to apply for scientific regulatory advice under the ongoing SNSA pilot project. SNSA stands for Simultaneous National Scientific Advice: The procedure allows drug developers to obtain scientific advice from medicines authorities in two EU Member States at the same time, saving time and money. In a further pilot phase set for August 2022, the possibility for more than two national medicines authorities to be involved in a consultation at the same time will be created.

Discussions with the BPI and other associations have been held annually since 2010. The regular meetings provide a platform to discuss both general and specific questions on clinical trials, marketing authorisations, follow-up procedures, and batch testing and to exchange experiences. They are thus an essential basis for the activities of the Paul-Ehrlich-Institut relating to the support and regulatory monitoring of drug development and lifecycle management in the interest of patients.

Updated: 03.03.2022