CFDA Launches New Drug Production License

Notice of the General Administration of Food and Drug Administration on the Re-issue of the Drug Production License and the Medical Institution Preparation License
The State Administration of Food and Drug Administration has decided to activate the new version of the Drug Production License and the Medical Institution Preparation License from January 1, 2016. The relevant matters are heeded as follows:
1. The State Administration of Food and Drug Administration has uniformly printed a new version of the Drug Production License and the Medical Institution Preparation License (see annexes 1 and 2). The positive and copy copies of the new "Drug Production License" and the "Medical Institution Preparation License" shall indicate the daily regulatory agencies, daily supervisors and supervision of the reporting telephone, implement the regulatory responsibilities and accept social supervision.
, according to the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China, both the Drug Production License and the Medical Institution Preparation License are valid for five years. Where the expiration of the validity period and the need to continue the production of drugs, the pharmaceutical production enterprise shall, in accordance with the provisions of the Measures for the Supervision and Administration of Drug Production (State Food and Drug Administration Order No. 14), submit the Application Form for a Drug Production License (Annex 3) and the relevant application materials (Annex 4) to the provincial food and drug regulatory department at the provincial level where the expiration of the validity period requires the continued preparation of preparations;
3. In order to facilitate unified management, the Pharmaceutical Production License and the Medical Institution Preparation License, which have not expired at the end of 2015, shall be replaced by the Food and Drug Administration of the provinces (districts and municipalities) by the end of 2015, with the validity period consistent with the original certificate.
Iv. Notice on the Implementation of the Quality Management Code for the Production of Drugs (revised in 2010) of the former State Food and Drug Administration (No. 101 of the State Food and Drug Administration) and the Notice on Speeding Up the Implementation of the Newly Revised Quality Management Practices for Drug Production to Promote the Upgrading of the Pharmaceutical Industry (The State Food and Drug Administration) Documents such as Ann (2012) No. 376 require pharmaceutical production enterprises (or production scopes) that have not been certified by the Quality Management Code for Pharmaceutical Production (as amended in 2010) as required, and may not produce drugs as of January 1, 2016, and shall not be issued with a new version of the Drug Production License (or corresponding production scope).
5. In accordance with the Notice of the General Administration of Food and Drug Administration on Strengthening the Supervision and Administration of Extracts and Extracts in the Production of Chinese Medicine (No. 135 of the Food and Drug Administration (2014) ), Chinese medicine extract production enterprises and Chinese generic pharmaceutical production enterprises (or production scope) that do not have the corresponding capacity for Chinese medicine extraction shall not be issued with a new version of the Drug Production License (or corresponding production scope).
this announcement.
: 1. "Pharmaceutical Production License" style
2. "Medical Institution Preparation License
3. Application form for drug production license
4. Request for re-issue of application information for "Drug Production License" (Bio Valley)