2010 Version Of "chinese Pharmacopoeia" Upgrade For The Pharmaceutical Industry

According to the plan, the 2010 version of "Chinese Pharmacopoeia "Will be the end

of August to complete all tasks and final research work Pharmaceutical Excipients The revised standards which are underway.

"New Pharmacopoeia Accessories Revision of the standard being finalized, it is estimated will ultimately included 138 varieties of accessories. Publication second draft has been completed now, by the end of August will be finalized. "Recently, the reporter was informed from the relevant source.

Recent years, the state attaches great importance to the medical accessories, medical supplies into the revised standard pharmacopoeia in this important part of the revision, medical supplies will significantly improve safety standards.

Increase your variety Yinzheng Long, chairman of Anhui province, said drug counseling, medical supplements currently in use are very broad scope, but many are not medical standards for pharmaceutical excipients, to restrain the development of pharmaceutical excipients. The current United States Pharmacopoeia set of accessories has reached more than 500 kinds of species, far higher than China's.

Present, about 90% of the pharmaceutical excipients used do not incorporated into the Pharmacopoeia standards. Since the standard lack of which can only refer to some of Pharmaceutical Excipients Chemical industry Standards Food Standards, standards and other industry-standard cosmetics. "Wants to expand the scope of pharmaceutical excipients were contained to reflect the medicinal properties of pharmaceutical excipients and indicators." Sichuan Province, the Director of Food and Drug Administration regulations, said Song Min-xian.

2010 edition of "Chinese Pharmacopoeia" will establish standards for pharmaceutical excipients, pharmaceutical excipients standards to address less obvious problems of poor quality, efforts to expand the scope of collection containing the frequently used accessories.

2010 Edition "Chinese Pharmacopoeia" was originally drafted standard varieties 205 kinds of accessories (including some commonly used excipients for injection), which revised 2005 version of 71 species, 134 species to be new, but part of the sample sources, lack representation , data, and test feasibility of the method is limited and policy-oriented, quality injection and other reasons, unable to meet quality standards of integrity, Pharmacopoeia 2010 edition contains the final collection of new accessories will be reduced to 66 species, including amendments to 2005 edition of 51 species, 21 kinds of semi-revised total of 138 collection contains more than a substantial increase in the 2005 edition, Yinzheng Long said.

"Some species will not be included in the supplement after another added into." Yinzheng Long said.

The Pharmaceutical Excipients species were contained in the basic principles: First, the common domestic species have been produced; Second, the domestic has been imported and domestic Pharmaceutical companies Has been widely used overseas accessories varieties; third is there food, chemical standards, and domestic Pharmacy More variety of enterprise applications, can refer to USP, EP, BP, JP appropriate to add, and convert the format or standard Chinese Pharmacopoeia, in principle, the standard should be really mature before they can income Pharmacopoeia; 4 is required for the development of new formulations Important accessories (not the amount, but at the forefront of the species, for the promotion of research and development of our new formulation is necessary).

To promote industrial upgrading Late start in China Pharmaceutical Excipients industry, industry concentration is low. Manufacturers in general is not strong professional, quality instability, small scale, variety and size small, the product really meets Pharmacopoeia standards are less certain domestic and imported accessories are significant differences in the quality of accessories.

Current implementation of standards for pharmaceutical excipients management and registration management (and new at the same time for approval) combined. Safety accessories will be gradually used for standard management, new accessories for the registration of general management, standard management after maturity, injection accessories to achieve the standard management of the road is longer, but the varieties included in this pharmacopoeia are almost no injection accessories.

Currently, only the accessories industry, regulatory policy introduced in March 2006 "GMP pharmaceutical excipients manufacturing practices", are non-mandatory policy, and the other is the State Food and Drug Administration Registration Department issued a "medicinal Accessories registration requirements, "only a temporary file, laws and regulations are not perfect.

by: heiyou

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