Compilation of Pharmacopoeia of People’s Republic of China (2010 Edition) Completed
The State Food and Drug Administration (SFDA) held a work conference for the distribution of the Pharmacopoeia of People’s Republic of China (The Pharmacopoeia) (2010 Edition) on 13 October 2009 in Beijing. When attending the conference, Mr. Wu Zhen, the Deputy Commissioner of SFDA remarked that the Pharmacopoeia is a code for drug quality control, safety, and efficacy. It is the essential component of the state drug standards which must be strictly observed in drug research, production, distribution, administration and management. Apart from being the largest collection ever, the 2010 Pharmacopoeia epitomizes the new achievements in drug standardization. It also incorporates the latest progress in safety and quality control as a result modern analytical technology.
The Pharmacopoeia of People’s Republic of China was first published in 1953 and the 2010 edition will be the ninth edition. It will be officially distributed in January 2010 and implemented on 1st July 2010. Unlike previous editions, the compilation and distribution of the 2010 edition have been entrusted to China Medical and Technology Publishing Society, a non-official channel. The target distribution volume is between 80,000 to 100,000 sets.
The Pharmacopoeia is the statutory technological standards for quality control of medicinal drugs. The final version of the 2010 Edition will take in 4615 items, of which 2215 have been revised and 1358 newly added. This is the most comprehensive collection so far. The new Pharmacopoeia will be published in 3 volumes, namely traditional Chinese medicines (Volume Ⅰ), chemical drugs (Volume Ⅱ) and biological products (Volume Ⅲ).
There have been major revisions in the appendices of the Pharmacopoeia (2010 Edition) also, with 47 additions and 162 revisions. In addition to the 1640 formulae of proprietary Chinese medicines (a 15% increase compared with the previous version), the new Pharmacopoeia has also included Chinese medicine Yin Pian in its “Instructions for Clinical Prescription”for thefirst time, with a total of 557 species. Vigorous promotion campaigns and extensive trainings will be launched by SFDA to ensure the smooth implementation and enforcement of the new Pharmacopoeia.
Piracy has long been the key concern in the distribution of the Pharmacopoeia and jeopardized the safety use of drugs. To tackle this problem, the new Pharmacopoeia has taken precautious measures in various steps of editing and production. Advanced printing technology and material have also been introduced to make it more difficult to replicate, thus preventing piracy. Moreover, a designated website has been put in place to facilitate online verification for the new Pharmacopoeia.
Sources:
The State Food and Drug Administration, PRC www.sfda.gov.cn
China News Publication Web www.chinaxwcb.com |
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