28 September 2008
New Drug Regulations in China Should Improve Drug Safety and Help Curb Corruption
2007 Drug Registration Procedure will also support Pharma R&D
China is expected to be the fourth largest pharmaceutical market by 2010. Since the first pharmaceutical joint venture in 1980, there have been 2159 joint ventures in China up to November 2002. All the top 20 major multinational pharmaceutical companies have established branches in China and multinational companies are choosing to conduct clinical trials in China for various reasons including the country’s large patient pool, relatively low cost and future sales potential for products.
The Drug Registration Procedure, a set of regulatory amendments concerning the registration of new drugs that came into effect on October 1, 2007 are primarily motivated by concerns over drug safety and curtailing corruption. The primary aims of the regulation are:
• To strengthen the safety requirements for drugs
• To specify the responsibility and strengthen the supervisory system
• To increase the drug registration standards and encourage novel drugs
Corruption in High Places
In the last couple of years, China has seen many former State Food and Drug Administration (SFDA) officials imprisoned on charges of graft. The Chinese administration displayed its keenness to crackdown on corruption and made an example of the former director of the SFDA, Mr Zheng Xiaoyu. He was executed in June 2007, when found guilty of corruption. The Guardian reports that Xiaoyu was found guilty of accepting 6.5m yuan (£433,000) worth of bribes from pharmaceutical companies to expedite the approval of new drugs.
Previous regulatory procedures were neither rigorous nor transparent. There were inconsistencies between the drug registration and supervision procedures. Past procedures mainly specified the acceptance, review and approval procedures. Yet, they laid out few requirements about the examination of the source documents, on-site inspection of the manufacturing facilities or inspection for to ascertain product quality. In April 2006 there was a series of large-scale serious adverse drug reactions (SADRs) which came to light.
Mr Liang Kong, author of a report titled “Drug Registration in China - An overview of Chinese Drug Registration Procedures” says, “Previously there were not enough supervisory measures in place. The submission documents from some applications were not systematically presented and fraudulent data was observed; this resulted in safety of some of the approved drugs being suspect.”
The report finds that since drugs were being approved even to minimum standards, the local industries’ enthusiasm for novel drugs was not being encouraged. Instead, there was mushrooming of simplified dosage changes and generic drug applications, enabling low quality copycat drugs to flood the market.
The revised drug registration procedure has been simplified to 15 chapters with 177 articles. It has more stringent requirements pertaining to authenticity, and ensures punishment for fraudulent data in R&D and submission.
An URCH Publishing study outlines all the key developments in China’s drug registration and approval process. It finds that these new set of laws form the core regulation guiding the conduct of clinical trials in China and are a revised version of those introduced in 2005. These new regulations will encourage openness and transparency and help clamp down on corruption in state agencies.
