TAV, scientific advice and Brexit in the focus of the meeting between PEI and the BPI
No matter whether the subject concerns the Therapieallergeneverordnung (TAV, Therapy Allergens Regulation), offers for regulatory scientific advice, or Brexit: These topics have in common that they require all actors to proceed in a harmonised manner.
"The active dialogue with associations of the pharmaceutical industry optimises the interfaces for development, marketing authorisation, and testing, and in doing so – ensures safe and effective biomedicines in Germany and Europe", explained Professor Klaus Cichutek, president of the PEI. For this purpose, the Paul-Ehrlich-Institut (PEI) invited representatives of the Bundesverband der Pharmazeutischen Industrie (BPI, German Pharmaceutical Industry Association) and pharmaceutical and biotech companies on 13 April 2018.
Points on the agenda included the implementation of the TAV, pursuant to which necessary efficacy data are collected for the purpose of a marketing authorisation for previously marketed therapy allergens, which have not been licensed yet. Currently, 71 therapy allergens are undergoing marketing authorisation procedures in accordance with the TAV, for which the PEI assesses the documents for quality, pre-clinical and clinical evaluation, and transmits the list of deficiencies. A harmonised regulation of test and therapy allergens throughout Europe is currently under discussion in the European CMDh Drafting Group on harmonization of the regulatory approaches for allergens and headed by Professor Stefan Vieths, vice president of the PEI. The current subject is the requirements for test allergens, in particular for rare allergens.
Representatives of the BPI have confirmed that there is a high demand for PEI's scientific advice as well as for joint advice offered by the PEI and the Gemeinsamer Bundesausschuss (G-BA, Joint Federal Association).To satisfy this demand, the PEI has already compiled the corresponding offer. An informal application for "joint advice" focusing on the early involvement of aspects of the evaluation of additional benefits can be made at the PEI via firstname.lastname@example.org.
Another important subject was the Brexit. After April 2019, the medicines agencies of the United Kingdom will no longer be available for procedures within the European Union (EU), as they used to be, due to the Brexit scheduled for next year. The PEI informed the participants that it was prepared to take on additional regulatory procedures which can no longer be performed by the medicines agencies of the United Kingdom.
Talks with the BPI and other associations have been taking place since 2010. They have proven their worth and will be continued.