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Revised Pharmacopoeia 2010 Edition Focuses On Standardization

This article was originally published in PharmAsia News

Executive Summary

The 9th Chinese Pharmacopoeia Commission, established in 2007, recently held a working meeting to discuss the revision of Chinese Pharmacopoeia 2010 edition (PharmAsia News, Feb. 4, 2008). The new directory will focus on raising the standards of TCM, biochemical drugs and injections. The revision will modify those drugs with weak standards or whose methodology cannot be duplicated, as well as eliminate drugs which are not applicable in clinical practice or which have quality control or potential safety risks. A separate injection drug commission will be in charge of collecting injection data and understanding existing problems based on specific subjects such as TCM, antibiotics and biological products. The commission hopes that suggestions contributed will help conceptualize a basic platform for the field. (Click here for more - Chinese Language)

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According to the Chinese Pharmacopoeia Commission, Chinese Pharmacopoeia 2010 edition is scheduled to be finalized in late August (PharmAsia News, Dec. 15, 2008). China Medico-Pharmaceutical Science & Technology Publishing House will start publishing and distributing the publication beginning in 2010, with the new standards taking effect July 1. Some major changes have been made in the explanatory notes, standards requirements, general principles of formulation and testing methodologies, with expanded appendices and an increased list of medicines. To ensure drug safety, the revision puts more emphasis on drug safety and quality controllability, adding more controlling index and testing methods. Specialized identification techniques are also included that cater to TCM's characteristics. (Click here for more - Chinese language)

Chinese Pharmacopoeia 2010 Edition To Raise Standards

Chinese Pharmacopoeia, the gold standard for medicine in China, has begun revising its contents. The 2010 edition will extend the record of chemical pharmaceuticals and TCM, adjust the standards of pharmaceutical technology and prepare a catalog of newly added drugs. The revised draft will be completed before the end of 2008. The pharmaceutical industry subscribes to the standards in Chinese Pharmacopoeia as the minimum basis for the quality of all drugs and production technology. With the Chinese authority's stricter supervision of adverse drug reactions, the revision is set to raise the standards for drug quality. (Click here for more - Chinese Language)

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