New standards for base drug quality have been developed in the pharmacopoeia

On November 15, the second plenary session of the Tenth Pharmacopoeia Committee and the 2011 China Pharmacopoeia Science Annual Conference were held in Beijing. The theme of the conference was "Science Leading, Simultaneous Development, and Practical Innovation." Chen Min, director of the Ministry of Health and chairman of the Tenth Pharmacopoeia Committee, Shao Mingli, director of the State Food and Drug Administration (SFDA) and executive vice chairman of the Tenth Pharmacopoeia Committee, Wu Jian, deputy director of the SFDA and deputy chairman of the Tenth Pharmacopoeia Committee, More than 300 members of the Pharmacopoeia Committee attended the meeting.

The reporter was informed at the meeting: As of October, the formulation of new standards for the quality of essential medicines in our country has been completed. The revised basic drug quality standards have been greatly improved in terms of safety, effectiveness, and quality controllability.

Increase after evaluation first

According to the overall deployment of the SFDA, the National Pharmacopoeia Commission (hereinafter referred to as the “Pharmacopeial Committee”) evaluates the drug standards involved in the National Essential Drug List one by one and adopts a method of first evaluation followed by improvement.

It is reported that in the work of improving basic drug standards, the pharmacopoeia has drawn reference to foreign pharmacopoeia and drug standards, combined with the actual situation in China, formulated scientific and reasonable working goals for the species that need to be improved, and ensured the pertinence and rigorousness of standard formulation work. Sex and science.

First, in accordance with the most advanced drug quality control concepts and technical requirements, the injection standard has generally been raised, and the examination items such as allergy, pyrogen, hemolysis, and coagulation of TCM injections have been revised, and feature map identification or fingerprinting check items have been added. . The second is that the varieties of Chinese medicine clearly define the name of the prescription drug flavored decoction pieces, and the method of concocting a plurality of varieties of decoction pieces is unified, and a limited number of examinations may be made on the tastes of some prescriptions that may be adulterated to ensure the authenticity of the feeding materials. Thirdly, the standard's specificity is stronger, and the application of liquid chromatography for chemical liquid chromatography has been further strengthened. At the same time, systematic examinations and verifications have been conducted on dissolution items, release degrees, and other inspection items, which are basically the same as European and American standards, and some standards are even high. In European and American Pharmacopoeia.

Wang Lifeng, secretary general of the Pharmacopoeia Committee, introduced at the meeting. This year, the Pharmacopoeia Committee organized 31 standard research units to implement the drafting, review, and review of standards, and completed the rest 285 of the Pharmacopeia standards that have been improved in 2010. A base drug improves quality standards.

It is reported that the upcoming edition of the “Chinese Pharmacopoeia (2010 Supplement)” also includes some standards for raising basic pharmaceuticals. In addition, some of them are issued in the form of a national drug standard (revised).

According to reports, the preparation of the 2015 edition of the “Chinese Pharmacopoeia” started last year, the selection of the currently selected varieties has been completed, and it will fully cover the National Essential Drug List and the National Medical Insurance Catalogue.

The new standard will comprehensively promote implementation

Wang Lifeng said that in the next stage, the Pharmacopoeia Commission will cooperate with relevant departments to fully implement the implementation of the new standard. In order to make up for the inadequacies of re-enactment, light implementation, and lack of feedback in past work, the Pharmacopoeia Commission organized and conducted special training in promoting the promotion and implementation of the 2010 edition of the Pharmacopoeia; earnestly collected feedback; opened a network implementation column and a Q&A mailbox; Timely understanding and mastering various information and trends in drug development, production, distribution, use, and other aspects of drug regulatory work and drug regulatory work.

Chen Hao emphasized at the meeting: “In the past three years since the reform of medical reform, the community has paid great attention to the basic drug system, especially the quality and safety of essential drugs. Strengthening the supervision of basic drug quality and safeguarding drug safety are related to the effectiveness of medical reform.

It is reported that in the future, the country will continue to increase funding support for standard setting and improvement work.