Biomedicine is booming
Antibodies, cell and gene therapeutics, and other biomedicines account for 35 percent of all clinical trials for which applications have been submitted, and this rate is increasing. This rapid progress requires co-ordinated action by all actors.
"With its advisory services in regulatory affairs, the PEI contributes to a continued optimisation of development periods up to the marketing authorisation and assures that biomedicines in Germany and Europe are safe and effective", explained Professor Klaus Cichutek, president of the PEI.
On 30 January 2018, the Paul-Ehrlich-Institut (PEI) hosted a meeting with representatives of the Verband der forschenden Pharmaunternehmen (vfa) (Society of Research-Based Pharmaceutical Companies) and companies from the pharmaceutical and biotech sectors. A dialogue is a significant requirement in supporting innovative biomedicines to prepare them for the marketing authorisation. Participants at the meeting exchanged information on regulatory requirements and discussed companies’ strategies to provide information on how clinical study programmes should be structured and how a goal-oriented marketing authorisation process can be guaranteed.
The agenda of the meeting included the transfer of know-how from European organisations, authorisations of clinical trials, and scientific advice. The PEI also informed the participants on the option of joint advice with the Gemeinsamer Bundesausschuss (G-BA, Federal Joint Committee).
Brexit was another topic discussed at the meeting. After the withdrawal of the United Kingdom from the European Community (EU), its medicines agencies will no longer be available for marketing authorisation procedures within the EU. The PEI informed the participants that it has prepared itself to take on additional duties in this area.
Talks with the vfa and the Bundesverband der pharmazeutischen Industrie (BPI, Federal Association of the Pharmaceutical Industry) have taken place annually since 2010.