CHINA REFORMS DRUG REGISTRATION IN UNREGULATED SECTORS

China's State Food and Drug Agency (SFDA) has issued new regulations obliging healthcare institutions to obtain registration for their medicinal products. From August, hospitals will be required to apply to register prescription drugs prepared on-site, a measure which could impact "informal" drug preparation and boost the regulated sector.

However, local reports note that the new rules will carry a number of important exceptions, with traditional Chinese medicines among the major product types to be exempted. Also escaping the registration requirements will be all currently available products, implying that many widely-circulating copy products will escape the new regulation. Indeed, products with active ingredients already registered with the SFDA will escape the rules, as will poisons, "biopreparations" except anti-allergics, and other unidentified categories which do not fall within the scope of SFDA regulation.

Despite the gaps in the new regulation, the requirement to hold a dispensing licence should bring some order to the prescription sector, especially in remoter areas where many medicines are prepared on-site at hospitals and access to relatively expensive conventional drugs remains difficult.