New SDA Regulations for Drug Product Registration in China

Authorities at the State Drug Administration (SDA) in China announced earlier this year that they are planning to implement nine new complementary regulations and methods for drug product registration in the country. These new regulations will be implemented from the end of 2002 into 2003. After the promulgation of the Implementing Methods for China’s Pharmaceutical Administration Law, the nine new regulations and methods will be implemented successively.

The SDA has in recent years been trying to address the problems and issues of drug registration in China. Some of the problems of the current drug regulatory system in China include: (1) non-integration of drug standards into China’s national regulation of drug products, (2) unclear and substandard regulations regarding drug packaging and inserts, (3) decentralized administration of drug evaluation, resulting in low quality generic drugs and counterfeits, and (4) imported drug registration regulations do not conform to WTO requirements.

On September 15, 2002, a new definition for new drugs was introduced into China. Instead of drugs not previously manufactured in China†the definition for new drugs has been changed to drugs not previously marketed in China. This change in definition places foreign and local drug manufacturers on a more level playing field. New indications for drugs manufactured locally would be treated in a similar fashion as imported drugs. In addition, the SDA plans to implement the Methods for Regulating Drug Product Registration (Methods) on December 1, 2002.