Domestic: Decentralization Of Part Of The National Assessment To Be The Right Medicine

In mid-September, the State Food Drug Administration (SFDA) Registration Department called Tibet

, Xinjiang, Inner Mongolia, Sichuan, Guangxi and other provinces, autonomous regions and Drug Administration Registry and the number of national-scale producers sit down and discuss drug thing?? How to improve national drug processing of applications for registration review, the State Department is developing the "support and promote the nation on Medicine The views of career development "(draft) offer advice and suggestions.

Attended the meeting in Tibet are Tibetan Medicine Co., Ltd. odd side bus Tsering, director of production was very excited to return to Nyingchi. Tsering told Palestinian side, "Chinese Economic News" reporter, the state will invest 24.5 million yuan to improve the national drug standards, and, given the unique nature of national drug regulatory department is exploring on the national drug regulatory approval to establish a complete evaluation system and earmarked special funds for construction projects to support national drug standards.

Independent evaluation system Graduated from the University of Shanghai Pharmaceutical Tsering on Pakistani side of the unique efficacy of Tibetan medicine and then sure enough. In 2005, he suffered from advanced liver cirrhosis by the West China Hospital, the best treatment is invalid, then the way to Lhasa, Tibetan experts turn to the end of treatment by Tibetan medicine specialist can be cured. In his view, folk medicine has a strange effect for many incurable diseases, helplessly subject to multiple factors, many of the nation has a unique effect of drugs can not benefit from more people. One new drug approval is a major factor.

It is understood that the current system of drug evaluation, largely ethnic Chinese medicine can not be differentiated and unique essence of revealed itself, and therefore, in order to approve the drug in the nation in a better combination of the characteristics of folk medicine, play therapy to promote its advantages, the National Bureau for national drug approval may be more reasonable and more inclusive, including Tibetan medicine, including national drug registration is expected to usher in a more scientific examination and approval system. It is understood that the closed-door meeting in mid-September to discuss the focus: to respect the uniqueness of their own ethnic medicine, SFDA will review aspects of national drug more attention to national medical experts.

The same time, China is still a blank for the current national review of methods of drug medicine, drug clinical guidelines, is also being discussed under development. Among them, establish and improve national drug quality control, validation and evaluation standards, and to make this evaluation system in accordance with modern principles of evidence-based medicine to prove safe and effective products and become a major key.

"National drug development is now the most urgent is to establish and perfect quality control, validation and evaluation standards, this standard must be consistent with national medical system characteristics, different from the separate system of Chinese medicine. Was built in evaluation of national drug approval system, the aim is to promote the advantages of better play. also the transfer of part of the review of the right to employ experts in family medicine, Chinese medicine is clearly respect the national laws are conducive to national drug development. "Tsering that the Palestinian side.

It is understood that, in order to strengthen national drug registration and management work, SFDA has been established, including Mongolian, Tibetan, Victoria drugs, including medical experts, review of expert database, the technical review of drugs, TCM protection and non-prescription drugs the selection of such work, were invited to participate in national medical experts to ensure the quality of national medicines review. In November 2007 established the Ninth National Pharmacopoeia The Commission also added a professional member of some national medicine, established the National Pharmaceutical Professional Committee.

"Including Tibetan medicine, including national drug has the characteristics of this nation, in the theoretical system and practice methods, and in the evaluation methods are different from Western medicine, folk medicine should be more suited to their characteristics and to promote its advantages to play evaluation methods. "Tibetan Autonomous Region vice president Tsering told Palestinian Professor Chu," Chinese Economic News "reporter, in the national drug review this piece, should pay full attention to the role of national experts in medicine, Tibetan medicine was once a lack of talent evaluation, but Through 10 years efforts have formed a team of experts have the capacity assessment.

"We have to do is to explore methods of Tibetan medicine review of new drugs, new drug clinical guidelines. Qizheng Tibetan Medicine will be a participant and facilitator." Tsering told reporters Pakistan border.

Lack of policy basis According to the characteristics of national drug

for the implementation of approval, delegated the right to review, the experts have had a voice. CPPCC, the CPPCC Vice-Chairman Chan Xunru Yunnan province has first meeting of the CPPCC to submit "national attention to the pharmaceutical industry on the development of proposals" (Code No. 1327), he thought, "To meet the national medical practice to develop new drugs criteria. on the efficacy and safety really the national pharmaceutical drugs to relax the approval criteria, delegated power to approve, by the approval of the national drug to allow its circulation in the region. "

Fact, was built in evaluation system of national drug policy is not without basis. SFDA2007 implemented in October, "Drug Registration", part of the State Council to exercise the functions entrusted to the Provincial Bureau, and the end of 2008 issued the "Supplementary Provisions of Chinese medicine Registration" demands "Tibetan, Uighur Medicine, Mongolian and other ethnic medicines management with reference to the registration provisions. national drug development should be consistent with national medical theory, the application of production enterprises should have the appropriate national drug professionals, production conditions and capabilities, the review should be organized for national experts in medicine. "

by: pretty

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