Registration of API, Excipients and Packaging Materials in China

China

China’s NMPA (former CFDA) has recently issued new regulations regarding the registration of active ingredients and other materials in China. The current regulations, many of very recent application, assmilate the management of Drug Master Files (DMF) to the procedures that are established by the FDA in US and EDQM in Europe.

The new regulatory environment, together the current conditions of the API market in China is making very interesting to European and US companies the commercialisation in China of API produced in their countries. According to the new regulations, very similar to the requirements existing in US, the marketing of an API in China will require the pre-registration of a DMF for the subsequent registration of a drug product by a pharmaceutical company, which formulates such API. This registration should be managed by the foreign company through a local agent in China.

TDV, with presence in China since 2006 through its affiliate company Shanghai TDV Pharmaceutical Consulting Co. Ltd. in Shanghai, is acting officially as Agent for API, excipients and packaging materials DMF registration in China according to the recent regulations.

 

The services related to DMS registration include administrative as well a technical support in the following tasks:

  • API & Excipient & Packaging Register in China NMPA (CDE).
  • Act as Registration Agency to communicate with CDE.
  • Administrative submission to obtain Registration number (filed as “Inactive” status).
  • Technical assistance during evaluation stage (when in “Active’ status).
  • Tracking registration status.
  • Dossier translation into Chinese; compile subsequent CDE requirements.
  • Dossier Revision.
  • Annual Report: preparation or assistance in the preparation.

 

If you are interested in more information, please email us.