China’s Cabinet Approves Plan to Strengthen Drug Safety

On December 7, 2011, China’s Cabinet approved a blueprint to boost the country’s drug safety over the next five years. Measures to improve drug safety include increased monitoring of pharmaceutical companies and a new credit rating system.

The 2011-2015 plan sets the general goal of “sharply” increasing the level of safety and consumer’s satisfaction towards drugs. All pharmaceutical products are to meet the standards of a newly revised regulation on the quality management of medical products by the end of 2015. According to the plan, China will strive to bring its standards for chemical medicines, biological products, and traditional Chinese medicine in line with international standards.

The plan also urges improvements in labs’ and health organizations’ capabilities to inspect drugs across the country, especially at the country and city levels. The goal is to improve the monitoring for adverse effects and drug abuse as well as the re-evaluation system for medicines, specifically high-risk drugs and TCM injections after they enter the market. Emergency planning should also be improved to ensure a timely and efficient supply of medicines for emergencies.

In addition, the plan urges authorities to speed up digitalization of drug supervision. Unified code management for approved drugs should be adopted and electronic supervision should cover all types of drugs. More efforts should also be spent on regulating the paths of distribution of medicines and reducing the number of middlemen in distribution.

Finally, the plan stipulates that those who manufacture or sell counterfeit drugs should be severely punished. Business people with a history of serious misconduct should also be banned from working in the pharmaceutical industry.