The China State Food and Drug Administration (SFDA) has beefed up its requirements on domestic contract manufacturers doing work for foreign drugmakers. Its aim is to prevent export counterfeiting, no doubt to further establish its credentials as a trusted, world-class supplier of APIs and finished drugs.
The new requirements affect existing and future drugmaker/CMO deals, says law concern Sidley Austin. For example, contractor agreements must be signed directly with the foreign drugmakers that hold the market authorizations for the products in question. Contractors having an agreement with a third party agent on behalf of the foreign manufacturer is no longer acceptable.
In addition, contractors must be identified on the finished products, and products supplied by contractors must be packaged. Chinese contractors will have to display their names and addresses on outer labels or inserts of finished products.
The Chinese regulator now requires packaging for all contractor production. Products must have an inner package with labels displaying names and addresses of the contract manufacturers.
- here's the rundown