China, US trade dialogue covers fake pharma and API quality

Counterfeit and substandard medicines and active pharmaceutical ingredients (APIs) featured prominently in US-Chinese trade negotiations held earlier this week in Hangzhou.

The 20th meeting of the US-China Joint Commission on Commerce and Trade (JCCT) saw China commit to strengthening its oversight and enforcement of the API industry and counterfeit pharmaceuticals by undertaking a range of initiatives, including the establishment of a Drug Master File system, according to a statement issued yesterday by the Office of the US Trade Representative (USTR).

The adoption of a DMF system could tighten up the sale of bulk APIs and other ingredients. At the moment ingredients used in China must have paperwork issued by the State Food and Drug Administration (SFDA), but there is no such requirement for material exported for use outside China.

The SFDA says it has no jurisdiction over this trade. It is thought that a functional DMF system, in which suppliers can be vetted and approved for sale of an ingredient by the SFDA, could help overseas companies identify reliable sources.

China also said it would step up enforcement of record-keeping requirements for companies that manufacture and sell APIs, and regulation of unregistered Chinese companies advertising and marketing APIs at foreign trade shows and on the Internet.

The USTR statement also indicated that China had identified the SFDA as its single point of contact for the Interagency Coordination Conference for Fighting the Production and Sales of Counterfeit Drugs.

China also agrees to share information with the US Food and Drug Administration (FDA) on the activities of the Interagency Coordination Conference, it added.

The meeting was chaired by US Commerce Secretary Gary Locke and USTR Ron Kirk, together with Chinese Vice Premier Wang Qishan.

The USA estimates that its pharmaceutical industry loses billions of dollars of annual revenues due to counterfeit medicines, every year.

The average reported value of counterfeit medicines seized in 2008 was over $5m, according to the USTR statement.