China proposes new supply chain regulations for pharmaceutical manufacturers

China's State Food and Drug Administration has announced a proposal that would tighten supply chain security for manufacturers of active pharmaceutical ingredients.

The new regulation would significantly increase the auditing and filing processes for companies that manufacture the ingredients that go into pharmaceutical and therapeutic drugs, particularly those with addictive or harmful potential, such as painkillers and stimulants. The law represents an aggressive step for the Chinese government in preventing substandard pharmaceutical ingredients from contaminating medicinal drug supply chains, International Pharmaceutical Quality reports.

Entitled "Administration of APIs and Pharmaceutical Auxiliary Materials," the requirements in the draft of the regulation would apply to all active pharmaceutical ingredients, traditional Chinese medicine extracts and pharmaceutical excipients, as well as "raw and auxiliary materials" used for packaging and containers that come into direct contact with drug products.

The report says that it is intended to clarify the "relationship between and the respective responsibilities of the drug product manufacturers and the [active pharmaceutical ingredients] and pharmaceutical auxiliary materials manufacturers … and more clearly define the drug product manufacturers as the primary responsible persons for the product quality."

The regulation, if implemented, will apply to marketed drug products registered in China, but not to exported pharmaceuticals or excipients manufactured in China, says supply chain consortium Rx-360.