Medical network, June 7, the state food and drug supervision and administration bureau released by the drug inspection report 2016, marked the important shift in drug supervision and management mode. Food drug administration of drug safety, supervision department jian-hua ding is pointed out that the focus of future drug regulatory will further shift in the direction of supervision and inspection, "we think in the future to explore drug production quality management practices (GMP) certification and drug production license" joining together of two certificate ", and strengthen the supervision of things afterwards ". 

 

Jian-hua ding, said in an interview with the media that the current drug GMP certification has devolved to drug regulatory department at the provincial level administration since January 1, 2016 no longer accepts the drug GMP certification application, drug GMP certification will no longer be the "umbrella" of the enterprise. 

 

Jian-hua ding said the drug GMP certification is a pharmaceutical production enterprise in the process of production should follow the basic, the inevitable requirements of pharmaceutical production process is inherently should be carried out in accordance with the specification, standard - that is, the specification is a continuous and dynamic process. He stressed that ensuring "continuous compliance" is the primary responsibility of the enterprise, which will increase inspections of businesses and products to promote "sustained compliance". 

 

"Drug GMP certification is awarded to drug firms a certificate valid for five years, even if the enterprises are not in accordance with the standard production will also think there's a government guarantee certification and to evade their responsibilities." Jian-hua ding said that in the future to cancel in advance in the form of certification and accreditation regulation, does not mean that will reduce the drug quality standard, drug firms will face more stringent inspection, especially not informed in advance of flight tests. 

 

Any newly established drug manufacturing enterprises according to the relevant provisions of the pharmaceutical administration law, subject to the enterprise the local people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative departments for approval and issue the pharmaceutical production license. No drugs shall be produced without the production permit for drugs. The pharmaceutical production enterprise must organize production according to the provisions of the regulations on quality management of drug production, which is formulated by the pharmaceutical supervisory and administrative department under the state council according to the pharmaceutical administration law. 

 

At present, the implementation of pharmaceutical GMP certification is on the basis of reference to international standards, began in March 2011, those who can not meet the requirements of the enterprise and production line are not allowed to production, the industry called "history's most strict certification". As part of the quality management system, drug GMP is the basic requirement of pharmaceutical production and quality management, designed to minimize pollution, cross contamination and confusion in the process of drug production, errors, such as risk, ensure sustained steady produce meet the requirements of the intended use and registration of drugs.