Circular of the State Food and Drug Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Health, on Accelerating the Implementation of the Newly Revised Good Manufacturing Practice to Promote the Upgrading of the Pharmaceutical Industry

Issued by Guo Shi Yao Jian An [2012] No. 376 on December 21, 2012

To the Food and Drug Administration (Drug Administration), the Development and Reform Commission, the competent departments of industry and information technology, and the Health Department (Bureau) of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps:

According to the overall goals set in the "12th Five Year Plan for National Drug Safety" issued by the State Council, the "12th Five Year Plan for Deepening the Reform and Implementation of the Medical and Health System during the" 12th Five Year Plan "period, and the" Industrial Transformation and Upgrading Plan (2011-2015) ", the order of drug production by the end of the" 12th Five Year Plan "needs to be further standardized, and the overall ability to ensure drug safety is close to the international advanced level, The level of drug safety and people's satisfaction with medication safety have significantly improved. Therefore, pharmaceutical production enterprises should fully implement the newly revised "Good Manufacturing Practice for Drugs" (hereinafter referred to as the newly revised GMP) by the end of 2015, effectively improve the level of pharmaceutical production quality management, and promote the sustained and healthy development of the pharmaceutical industry. The following is a notice on accelerating the implementation of the newly revised drug GMP and promoting the upgrading of the pharmaceutical industry:

1、 Effectively grasp the implementation of the newly revised drug GMP work

Since the implementation of the newly revised drug GMP in March 2011, various regions and departments have closely cooperated and increased publicity and implementation efforts. Some drug production enterprises have taken the lead in passing certification and played a good demonstration and leading role. As of October 2012, all or part of the workshops of 535 enterprises have passed the newly revised drug GMP certification. However, overall, there is still a significant gap between achieving the expected goals. In some areas, progress is slow, and a few enterprises have a wait-and-see mentality. The problem of uneven implementation progress is still prominent, especially in the production of sterile preparations, which is particularly urgent to achieve the expected goals by the end of 2013.

All regions, departments, and pharmaceutical production enterprises should fully recognize the importance of implementing the newly revised GMP for maintaining public health, promoting social harmony, ensuring the smooth progress of medical and health system reform, promoting the adjustment and upgrading of the pharmaceutical industry structure, and enhancing enterprise management level and international competitiveness. This should be taken as a key task for the current and future period of time. We need to further unify our thinking, improve our understanding, and correctly handle the relationship between local and overall, progress and quality, software and hardware, current and long-term, corporate responsibility and government regulation. We must seize this opportunity and take measures such as technological transformation and mergers and acquisitions to eliminate outdated production capacity and increase industrial concentration. We must adhere to the requirements of not lowering standards and not relaxing time to ensure that the implementation of the newly revised drug GMP meets the expected goals.

2、 Encourage and guide drug production enterprises to achieve the newly revised drug GMP as soon as possible

(1) Encourage the concentration of drug production towards advantageous enterprises. Support the upstream and downstream integration between enterprises such as R&D and production, manufacturing and circulation, APIs and preparations, Chinese medicinal materials and traditional Chinese patent medicines and simple preparations, and support enterprises to open