China registration of API (active pharmaceutical ingredients) support companies applying for drug marketing authorizations in reference to their DMF (Drug Master File) data.
Companies with business in China should always be aware of the risks involved and keep themselves informed about the latest changes with the pharmaceutical requirements in order to stay compliant in China. The webinar “Challenges for China Registration of API” is part of the 25th APIC/CEFIC Global GMP & Regulatory API Conference held live in Amsterdam and streamed online.
The webinar informs you about the current API regulatory framework in China, and provides analysis and comparison between EU and China markets.
Date and Time
Session E on October 27, 2022, 8:30am – 5:00pm (CEST)
- Organizations and Regulations
- Introduction of the complete process with timeline and fees
- Testing at NIFDC in China
- Introduction of application documents
- Comparison EU & China
- Common deficiencies from the perspective of a EU manufacturer
- Mr. Stefan Fischer – Managing Director of the Cisema Group
- Mr. Guo Ning – General Manager of Cisema Beijing
As part of the registration of pharmaceuticals, manufacturers must submit the DMF (Drug Master File) number of the pharmaceutical packaging and ingredients. Cisema can support the applicant during the preparation of the supplementary dossier and the second NMPA technical evaluation. We can help provide the required technical documents or test data in this supplementary phase. In addition, Cisema can also support for the following:
- Advice on applicable legislation and regulations.
- Determining whether your products need NMPA approval.
- Analysis of ingredients for compliance with Chinese regulations.
- Legal representation in China as NMPA Legal Agent for registration and regulatory affairs and protecting your independence.
- Application for China NMPA registration.
- Provision of complete document checklist and templates, including advice on the correct completion.
- Translations and notarizations.
- Provision of comprehensive test sample list.
- Close follow up of your sample tests in China.
- Communication and coordination between you and the Chinese authorities in technical and cultural terms.
- Provide response proposal of technical reviews by CDE.
- Assist site inspection initiated by CDE & CFDI.
- Follow-up support during the NMPA application of pharmaceuticals containing API or Drug.
If you would like assistance in the application of your API registration or other pharmaceutical projects, contact Cisema.
Cisema is a CRO and regulatory affairs consultant for China and has 12 offices globally with nearly 100 full-time employees.