State Food and Drug Administration: Linking the newly revised GMP certification and drug registration approval

2012 is the key year for the implementation of the newly revised pharmaceutical GMP. In particular, for sterile drug manufacturers, there is currently only a period of implementation of less than 2 years.

The survival of the fittest will be

Wu Wei, deputy director of the State Food and Drug Administration (SFDA), emphasized at the 2012 National Conference on Drug Safety Supervision that, through the implementation of GMP, it is necessary to strive to achieve three basic goals: to improve drug quality, promote industrial upgrading, and eliminate backward production capacity. Therefore, enterprises with basic implementation requirements should be urged to pass certification as soon as possible in order to play a leading role; for enterprises with poor corporate foundation, large investment in transformation, no market for products, and insufficient technical personnel, they should encourage them to withdraw or Mergers and reorganizations of advantageous companies.

For this reason, the SFDA requires provincial governments to do a good job of classifying and guiding pharmaceutical production companies. The provincial bureaus are required to make detailed investigations of drug production enterprises within their jurisdictions, and to grasp the first-hand truthful materials such as product structure, market size, supply and demand, and transformation or new construction plans, so as to carry out classified guidance.

Li Guoqing, Director of the Department of Drug Safety Supervision at SFDA, reiterated that through the implementation of GMP, it will promote the structural adjustment and industrial upgrading of the entire industry, and through the withdrawal of disadvantaged enterprises, form the survival mechanism of the inferior of the pharmaceutical industry.

Connect with registration approval

Wu Hao pointed out at the meeting that it is necessary to adhere to the unification of certification standards, and it is forbidden that the situation of loosening and loosening of standards will occur. The SFDA will step up inspections and spot checks. The provinces that are not strictly involved will be severely dealt with and their qualifications suspended if necessary.

In order to make significant progress in the newly revised GMP promotion work in 2012, SFDA has laid the following tasks:

First, it is necessary to strengthen the revision of normative documents. The regulatory documents that need to be revised include: Herbal Medicine Pieces, Medical Oxygen, Radioactive Drugs and Validated GMP Addendums, Drug GMP Certification Risk Assessment Standards, Drug GMP Certification Scope Filling Standards, and Drug GMP Certification Body Quality Assurance System Requirements.

Second, all provincial bureaus are required to strengthen the construction of drug certification and inspection institutions. Improve the internal working mechanism of drug certification and inspection agencies, establish and improve the quality assurance system, and adhere to the standards before and after certification. Actively explore the establishment of a full-time drug GMP inspector team to improve the level of drug GMP supervision and management.

In addition, strengthen the supervision and random inspection of the provincial bureau certification work, organize a supervision and inspection team at the appropriate time this year to supervise and inspect the GMP certification work in key provinces to ensure the consistency of the implementation of the certification standards and promote the progress of the balance; to strengthen the process of GMP promotion Investigate and investigate the progress of GMP promotion in some provinces (cities, districts) to understand the opinions and suggestions of enterprises and regulatory authorities during the process of the new revision of GMP; and public opinion and propaganda for the new revision of drug GMP is also a key work this year.

It is reported that in order to better advance the implementation of the newly revised GMP, the SFDA is formulating relevant policies to link the newly revised GMP certification work with drug registration acceptance and approval work. If the company fails to pass the newly revised GMP certification within the specified time limit, SFDA will not accept and approve the application for registration of drugs submitted by the company. (Reporter Li Yunming)