Announcement of China Food and Drug Administration on Enabling the New Edition of Pharmaceutical Production License and Dispensing Permit for Medical Organizations (No. 171 of 2015)

China National Food and Drug Administration has decided to enable the new edition of Pharmaceutical Production License and Dispensing Permit for Medical Organizations since January 1, 2016. The relevant matters are hereby announced as follows:

1. China National Food and Drug Administration prints the new edition of Pharmaceutical Production License and Dispensing Permit for Medical Organizations in a unified way (see Annex 1 and 2).  Both the genuine version and copy of the new edition of them shall be marked with the daily supervision organization, the daily supervisor and supervision telephone number, so as to implement the supervision responsibility and accept social supervision.

2. According to the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, both the term of validity of the Pharmaceutical Production License and Dispensing Permit for Medical Organizations is 5 years. Pharmaceutical production enterprises needing to continue producing pharmaceuticals after the term of validity expires should submit the Application Form for Pharmaceutical Production License (Annex 3) and relevant documents (Annex 4) in accordance with the provisions of the Measures for the Supervision over and Administration of Pharmaceutical Production (No. 14 Order of China Food and Drug Administration); and medical institutions needing to continue preparing pharmaceuticals after the term of validity expires should, in accordance with the provisions of Measures for the Supervision and Management of Preparation Confecting by Medical Institutions (No. 18 Order of China Food and Drug Administration), put forward application for renewal to the provincial food and drug administration they belong to.

3. In order to facilitate the unified management, the food and drug administration of all provinces (autonomous regions, municipalities) shall replace new version of licenses before the end of 2015 for those Pharmaceutical Production License and Dispensing Permit for Medical Organizations that have not yet expired by the end of 2015. The expiry date shall be the same with that of the original license.

4.According to the requirements of the Notice of China Food and Drug Administration on Implementing the Good Manufacture Practice of Medical Products (revised in 2010) (Guo Shi Yao Jian An [2011] No. 101), Notice on Speeding up the Implementation of the Newly Revised Good Manufacture Practice of Medical Products to Promote the Relevant Issues of Pharmaceutical Industry Upgrading (Guo Shi Yao Jian An [2012] No. 376), and other documents, the pharmaceutical production enterprise (or production scope) that fail to pass the certification of the Good Manufacture Practice of Medical Products (revised in 2010) in accordance with provisions shall not produce drugs since January 1, 2016, nor shall be granted the new version of Pharmaceutical Production License (or corresponding production scope).

5. According to the Notice of China Food and Drug Administration on Strengthening the Supervision and Management of the Extraction during the Production of Traditional Chinese Medicine and Extracts (Shi Yao Jian Yao Hua Jian [2014] No. 135), traditional Chinese medicine extract production enterprises and the traditional Chinese medicine production enterprise (or production scope) shall not be granted the new version of Pharmaceutical Production License (or corresponding production scope).

Information Source: China Food and Drug Administration