The 2010 Chinese Pharmacopoeia is a new and revised version of the 2005 Chinese Pharmacopoeia. Completed in 2009, it will come into effect October 1, 2010. Manufacturers in each Chinese province are expected to adhere to the contents. One of the most time-sensitive updates is that all drug manufacturers must make any necessary changes to adhere to the Pharmacopoeia’s guidelines for specifications and labeling by October 1, 2010. This may require filing supplemental applications to the provincial FDA.
The 2010 Chinese Pharmacopoeia acts as the national legal source to ensure drug quality control, drug use safety, and drug efficacy. It also includes standards for national drug development, manufacturing, operations, use, and management. Drawing from foreign drug standards, the book includes recent innovations, developments, and evidence-based foundations.
The book is split into three volumes for traditional Chinese medicine (TCM), chemical drugs, and biological products. In total, there are 4,600 varieties of drugs covered – 1,300 of which are new. The drugs in the new National Essential Drug List and the National Medical Insurance Drug List have also been incorporated.
Updates and new information have been focused on increased safety inspection requirements and standards for high risk drugs, TCM, and drugs with heavy metal or other harmful elements.