The new drug regulation introduced by the Chinese government in early October includes no definition of a New Chemical Entity (NCE), which means the State Food and Drug Administration (SFDA) has no way of identifying an NCE among the products for which it receives approval applications, international drugmakers have been warned.

The SFDA is therefore also unable to assure manufacturers applying to have their NCEs approved that their data will remain confidential, according to Chen Yang, an attorney in the Beijing office of international law firm Sidley Austin. Moreover, she warned that, while SFDA officials are required to maintain data confidentiality during their review of new drug applications, there have been reports that this requirement is not always adhered to, and she therefore advised manufacturers to “be careful” with the data which they supply to the agency with their new drug filings, PharmaAsia News has reported.

Another problem for the industry is that China’s new regulation removes the previous obligation on the SFDA to revoke the marketing approval of any product found to have infringed a patent, said Ms Yang. Patent disputes in China are dealt with by the courts and do not affect the drug approval procedure.

During 2007, the SFDA has issued 53 regulations relating to drugs, medical devices and foods, and over the next year it will produce new requirements for Good Manufacturing Practice (GMP) and drug safety reporting. There will also be new rules covering “special” (fast-track) approvals but these have yet to be finalised, and it is not currently clear whether they will apply to imported products, said Ms Yang. She also noted that China’s patent law is to be revised in the coming year, and among the amendments which could be added are a compulsory license provision in the event of a public health emergency and a “Bolar” provision, under which generics makers would be permitted to use the technology of a patented drug, ahead of its patent expiry, in order to produce and market their versions as soon as the patent expires.

Fast growth continues for Chinese pharma trade
Meantime, China’s pharmaceutical trade grew 24.3% in the first 10 months of this year to total $31.2 billion, with exports accounting for $19.8 billion of this and imports for $11.4 billion, according to new data published by the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE).

The agency forecasts that, over the next few years, Chinese pharmaceutical trade will continue to increase at a fast rate, with sales in the country’s major cities showing particularly significant growth, and also that China, India and Singapore will become the major Asian players in the world market. To date, 317 Chinese firms have successfully applied for the US Food and Drug Administration's Drug Master File, while 160 products made by approximately 80 Chinese firms have received the European Directorate for the Quality of Medicines’ Certificate of Suitability and eight Chinese makers hold the European Union (EU) certificate of GMP, it says.