Restructuring of China’s SFDA: more powers to increase efficiency

Food and cosmetic companies need to keep abreast of the recent restructuring of the SFDA. Significant changes have occurred in China regarding the administration of food and cosmetics.

The State Food and Drug Administration (“SFDA”), although merged with the Ministry of Health (“MOH”), has been granted powerful approval rights. Under this new regime, SFDA remains the competent authority for food and drug businesses. The only differences are that SFDA is no longer the authority issuing ministerial orders and its high level officials shall be appointed by MOH.

According to the Regulations on the Compilation of Major Responsibilities of Internal Departments and Personnel of the SFDA, the SFDA shall take over the part of the functions of the MOH and handle food sanitation of canteens and restaurants and cosmetic (both domestically manufactured and imported) related approval formalities and supervision in addition to its existing powers of approval of drugs, health care food products and medical devices.

On the one hand, cosmetics approval power has been officially transferred from MOH to SFDA on September 1, 2008, according to a circular jointly promulgated by the MOH and the SFDA on August 20, 2008. A new circular was issued on September 9, 2008 to officially publish the general rules as to how to handle cosmetic approval formalities. It is expected that various related circulars will be issued to transfer the different powers of MOH to SFDA over the next months.

Different functional departments have been restructured or established within SFDA to handle these additional approval and supervision roles. Worth mentioning is the establishment of the Food Licence Department, Food Security Control Department and the restructuring of the Supervision Department and their internal divisions to handle these new assignments.

On the other hand, SFDA’s responsibility of selecting national essential drugs and publishing the catalogue which is the basis of selecting reimbursed drugs will be transferred to the MOH. Such a transfer implies less influence of SFDA on the drug reimbursement policy.

The purpose of such restructuring is to coordinate the powers of SFDA and MOH, to increase work efficiency and mitigate risks of corruption.