With the official launch of the new medical reform, the State Food and Drug Administration also waved the "double knife" determination to conduct a "big cleanup" in the field of pharmaceutical production. At present, the new version of the "Good Manufacturing Practices" (GMP) is being revised and widely consulted. At the same time, the re-registration of drugs has been fully carried out. It is reported that this "big clean-up" aims to eliminate varieties that do not have production conditions, quality is not guaranteed, and safety risks are high.

Drug re-registration started

In fact, China's current GMP has been enacted and implemented in 1999 for a full 10 years. However, due to the many deficiencies exposed, the State Council issued the "Notice on the National Action Plan for Rectifying and Regulating the Drug Market Order" (hereinafter referred to as the "Notice") in July 2006. Since September of this year, the State Food and Drug Administration has The revision of GMP was officially launched. Recently, it was revealed that the Food and Drug Administration is actively promoting the revision of the new version of GMP. The new GMP will emphasize pharmaceutical production and drug registration and post-marketing supervision, requiring enterprises to establish a comprehensive quality assurance system and quality risk management system, as well as new quality licensors, quality risk management, product quality review and analysis.

Since August of this year, another drug re-registration review and approval work has been officially launched. Zhang Wei, director of the Drug Registration Department of the State Food and Drug Administration, admitted that drug re-registration is a routine work in drug registration management, but this re-registration is one of the special tasks in the Notice and the drug is re-registered. The work must be combined with the work of drug approval number check, drug production process and prescription verification. Therefore, the drug re-registration work is actually an in-depth and continuation of the special rectification work.

According to the requirements, by September 30 next year, all the varieties whose approval documents have expired must be re-registered, and the varieties that have not been approved for re-registration will not be available for sale.

Inventory low-standard idle drugs

What worries the industry is that the last large-scale cleanup occurred after the accident of the former State Food and Drug Administration, Zheng Zheng. Since then, the state has been very strict with drug registration. From the approval situation, from January to June 2009, the State Food and Drug Administration approved 173 clinical applications for new drugs, 238 new drug production applications, 1074 generic drugs applications, and 388 imported drug applications. The total number of drug registrations decreased, the quality improved significantly, and the structure changed.

This time, the re-registration of drugs took place in the context of the implementation of new medical reforms in the country. The intensity of the inventory can also be imagined.

According to the statistics of the State Food and Drug Administration, in the special rectification of the previous drug development process, 4337 approval documents have been written off through the drug approval number check, and 25,000 backlogs have been processed through the centralized review of the transitional varieties. The 15,000 varieties were not approved, and the approval rate was 61%.

Zhang Wei said that at present, more than half of the approval numbers of many pharmaceutical manufacturers are idle, and the proportion of varieties produced per year accounts for less than one-quarter of the total approval number of enterprises. While a large number of approved documents are idle, there are still a large number of pharmaceutical manufacturers applying for new registration approval numbers, which not only wastes social resources, but also is very unfavorable for drug production supervision, re-evaluation of listed drugs and monitoring of adverse reactions. Therefore, the re-registration of the drug will eliminate those varieties that do not have the production conditions, the quality is not guaranteed, and the safety risks are high. In the future, variety management will also change from “static” to “dynamic”, paying more attention to the normal production and normal sales of drugs.

Encourage innovation to curb low levels of duplication

After concentrating the technical force to clean up the problems left over from history, the SFDA hopes to completely reverse the passive situation of drug review and approval, and to direct drugs from the current low level to raise standards and encourage innovation.

It is reported that last year, the central government allocated 100 million yuan to raise the standard of 1,000 drugs in 2008. This year, it plans to arrange nearly 200 million yuan to support the standard improvement work. This is unprecedented. The increase in this standard will be tilted towards varieties with high safety risks such as injections, ethnic medicines, and varieties listed in the national essential medicines list.

In addition, the State Food and Drug Administration recently issued the fourth supporting document for the registration of drugs, the “Regulations on the Registration of Pharmaceutical Technology Transfers”. Since then, China's drug registration management system with the core of the Drug Registration Management Measures has taken shape, and China's drug registration has entered an era of encouraging innovation and guiding innovation.

Zhang Wei said that after the promulgation of the "Regulations on the Registration of Pharmaceutical Technology Transfers", once the technology transfer was approved, the approval number that had been obtained at the same time was cancelled at the same time, avoiding a single transfer, guiding the pharmaceutical manufacturers to reduce the simple change of dosage forms and generic drugs. The number of declarations fundamentally solves the problem of low level of duplication and homogenization.

Foreign-funded pharmaceutical companies are optimistic that in the past, it took 13 years or so for localized production to allow imported drugs to land. After the new regulations were introduced, the import of imported drugs into local domestic production became a simple change in property rights. Approved within one year. This will help foreign companies integrate resources and transfer foreign production to China.

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