Drug Standard Upgrade Speed export barriers dispute behind the market - the standard, basic medicines - pharmaceutical industries

Drug Standard Upgrade Speed export barriers dispute behind the market - the standard

, basic medicines - pharmaceutical industries

State Department in April 2007 promulgated the "State Food and Drug" Eleventh Five-Year "Plan", proposed action plan to improve national drug standards, to fully enhance the Drug Quality Level of control. In the "Eleventh Five-Year Plan" period, China to complete the 4000 ministerial standard varieties of proprietary Chinese medicines, chemical drugs Ministerial Standard 500 varieties, early drug regularized standard upgrade the standard of 300 varieties, development of common Pharmaceutical Excipients 223 kinds of standard, complete 1000 kinds of Chinese herbal medicine and 500 kinds of Chinese Herbal Medicine to formulate and revise national standards.

Held in January this year, the National Health Conference, Health Minister Chen Zhu stressed the need to continue to accelerate the implementation of action plans to improve national drug standards, give priority to raising standards of national essential drugs, to speed up Pharmacopoeia Revision. This year in April, the new medical reform program officially announced "the establishment of national essential drug system, a number of common diseases will be the drug of choice to provide high quality, sufficient number of security", "by strengthening quality control, efforts to make equitable access to safe and effective urban and rural residents essential drugs "and other expressions of basic drugs on a higher quality control requirements.

Financial support to upgrade the standard speed

"2008, we organized a 2010 version of" Chinese Pharmacopoeia "in preparation, also secured a 100 million yuan of state financial support, launched the 1000 varieties of quality standards for the revision of medicines and accelerate the 'National Drug standard to improve the work plan 'implementation. in 2009, our goal is to complete the 2000 species of standard revision. "State Food and Drug Administration drug registration Secretary, Zhang said.

Comprehensive listing of drugs to enhance the standard, "to achieve chemical standards with international standards", "Chinese standard upgrade, more secure control" is Zhang and his colleagues for the next few years the goal.

Fact, in order to strengthen drug supervision and management, to change the part of the national drug standards have lagged behind China's pharmaceutical production and quality control technologies, according to "food and drug safety," the general requirements, 2004, the National Council on the formulation to improve National Drug Standards action plan.

"As the capital, for objective reasons, the action plan has been slow," Zhang explained that the real acceleration of pharmaceutical standards to improve programs start from the 2008's 100 million yuan of special funds to support country began. Through this action, "and gradually improve standards of scientific and standardized management system, the establishment of drug standards elimination mechanism, integrated use of re-evaluation, re-registration and other means to firmly out of prescription, process and formulation unreasonable, there are serious security risks of species" is the proper meaning of this action.

It is understood that the standard of medicine in China mainly by the "Chinese Pharmacopoeia", Department of (Board) issued standards, standards for registration and processing standard provincial Chinese herbal medicine and Pieces etc., and to reflect the text standards and physical standards. China's national drug standard formulation and revision by the State Council administrative department drug regulatory organization Pharmacopoeia Committee. "Chinese Pharmacopoeia" 1953, compiled from published version 1, 2005 edition, "Chinese Pharmacopoeia" is the 8th edition of the; 2010 version of "Chinese Pharmacopoeia" was the preparation of a comprehensive start in late 2007, the upcoming second half of 2009 deadline, is currently in intensive review, final stage.

"Adhere to standards to improve product quality standards and advanced the principle of production for many of the same species, formulation of standards achieved on high not to low, to accelerate the gradual integration of international standards similar to standards of Chinese medicines safety and quality control aspects of the gradual integration with the international advanced standard. "National Pharmacopoeia Committee Deputy Secretary-General Zhou Fucheng to reporters about the 2010 version of" Chinese Pharmacopoeia "in the formulation of objectives.

Zhoufu Cheng explained that in the 2010 version of "Chinese Pharmacopoeia" in the revision and upgrade the standard work, for the same prescription, clinical efficacy of the same species of different series of dosage forms, in the implementation of standards, amend or adjust the relevant content, assignment are focal points of similar products as possible to a unit commitment of both cost and time savings, but also conducive to family unity of the standard specification. "Otherwise, different demands on the series of varieties, will lead directly to pharmaceutical manufacturing enterprises in the quality control of unfair, leading to unfair competition in the pharmaceutical market." Zhoufu Cheng said.

"Pharmaceutical standards is the embodiment of national drug development is the work of the technical basis for drug administration. To strengthen drug standard management, improve the quality of drugs, drug administration is an important aspect of the work." Zhang pointed out that in our current national drug standards, a considerable number of varieties of the standard level is not high, especially to the rise in the country is fairly conspicuous target species. Occurred in recent years, several security incidents caused by drug quality, and the State Bureau of injections carried out by prescription and process verification, all exposed parts of the standard drugs defects.

At the same time, Zhang believes that technical standards for pharmaceutical drugs is registered to carry out the technical review of scientific evidence, but also prescribes guidelines for development of reporting. At present, although there are a lot of technical standards promulgated, but the demand for drug development and the new revised "Drug Registration" demands the implementation there is a gap in comparison: first, not the early implementation of technical standards to be revised, the new " measures "in some of the requirements can not fully reflected in the technical standards; Second, technical barriers to entry are not high enough after the implementation of the assessment; Third, systematic technical standards is not strong, broad coverage is not and can not play a role as possible . Therefore, the standard raise and drug testing must be combined with the re-evaluation, to speed up drug standards to improve the implementation of the Action Plan.

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