Pharmaceutical Business review

China imposes new regulations on pharma donations

Medicines which have not been approved by the SFDA and foreign-made drugs and devices which have not received approval in their country of origin, or which are approved for use in clinical trials only have been prohibited. All donated drugs and medical equipment must be at least six months within their expiry dates, and severe penalties will be imposed on the donation of drugs which prove to be counterfeit or substandard.

There are also strict controls on the Chinese agencies which can accept drug donations from overseas. Drugs and other supplies may also legally be sent to the China Charity Federation and its branches, plus provincial and central departments of health and civil affairs. The SFDA has also said that the $500 million budget allotted for drug and food supervision in 2006-07 has equipped 90% of provincial drug control departments, and 60% of those at city level, to conduct full-scale testing as part of the SFDA’s drive to improve all stages of the drug supervision process, in order to combat counterfeit drugs and keep consumer prices down.

Shao Mingli, head of SFDA, has announced a major program of joint working with other government agencies to crack down on illegal on-line drug sales. The initiative is expected to provide support to some-widely used portals to help them self-police against illegal drug advertising.