Member of Medicines for Europe
Medicines for Europe is the official trade association for the European generic, biosimilar and value-added pharmaceutical industry, representing, supporting and developing scientific and technical interests within the European Union. Medicines for Europe Member Companies supply over 62% of all medicines in Europe covering 80% of therapeutic areas including high blood pressure, diabetes and cancer.
BioPharma Services is therefore proud to be a Partner Member of this strong and united Association which allows us to have a voice at a European level on all matters affecting the sustainability, competitiveness and regulatory environment of our industry.
Our work in China
BioPharma’s experienced scientific team includes members of Chinese origin with extensive in-country networks allowing for close communication with the NMPA – National Medical Products Administration (formerly CFDA – China Food and Drug Administration) and other key individuals in the Chinese market. Our experience in the Chinese generics market includes:
- Conduct of bioequivalence trials for NMPA submission
- Conduct of bioequivalence trials for joint submission to USA and European regulatory agencies (NMPA/FDA and NMPA/EMA)
- Program development and scientific consultation for conduct of 505(b)(2) trials for FDA/NMPA submission
- Support for ICH and Policy 80 format Clinical Study Report (CSR) for NMPA submission for FDA study submission
- Access to Chinese partners for sponsor’s study document translation and submission to NMPA
With the rapid development of the Chinese market and the expected restructuring of NMPA in 2019, we invite you to connect with us for the most up-to-date guidance on current regulations and the impact on your clinical trials.