China’s State Food and Drug Administration (SFDA) to Regulate API

The SFDA, with the aid of pharmaceutical industry associations, is pushing hard to stop the illegal manufacture of active pharmaceutical ingredients (API) and intermediates in China.

The SFDA announced its plans in June to set up an API supervision network, accessible through the Internet. All API manufacturers will need to register every transaction, including details on the buyer and the actual API. In addition, the buyer will have to record transaction details. This way, the SFDA can keep track of API stocks and manufacturers to quickly determine which sales may be illegal.

In addition, with the upcoming 2008 Olympics, the government has cracked down on allowed pollution levels for API manufacturing. Companies failing to stay within these levels will not be allowed to export their products.

Usually, an API manufacturer in China needs production approval from the SFDA. Good Manufacturing Practice compliance has also been a requirement since 2004. But wide enforcement has only come about recently. Earlier incidents, such as the dangerous heparin exported the US, have been linked with API manufacturers not registered or approved by the SFDA.

The US Food and Drug Administration had earlier made recommendations earlier to the SFDA on monitoring the export of drugs, such as cephalosporins and gentamicin sulfate (antibiotics). Other drugs include sildenafil (Viagra) and heparin. Firms exporting these products will need to get approval from the SFDA and also certification from the US.

The Chinese government hopes that its new regulations will help re-organize and better control the API sector. As smaller companies are unable to keep up with new requirements or are acquired by larger companies, the government aims to have a market with fewer key players that are more easily regulated.