China’s 12th National People’s Congress has approved a plan to establish a ministry-level agency named China Food and Drug Administration (CFDA), which replaces the State Food and Drug Administration (SFDA). The agency has started a reorganization under the leadership of a new commissioner, Mr. Zhang Yong.
Since March 22, 2013, SFDA replaced the sign on its headquarters with a new sign that has its new name in Chinese, and also began displaying the new name on the agency’s official Chinese and English websites, showing “China Food and Drug Administration” as its English name. The agency has announced that all of the previous functions of the SFDA have been merged into the new CFDA.
As a result of this restructuring, CFDA will be a full ministry agency reporting directly to the State Council, which is China’s highest administrative body.
This new development seeks “to strengthen regulation and boost people’s confidence in the country’s food and drug products” by eliminating “blind spots” and overlaps in regulatory authority, according to a Chinese official.
The Chinese government has also stated that this change will help to promote regulatory oversight and identify responsible parties, especially with respect to the regulation of food, which has been undertaken by SFDA and several other government ministries and agencies.
The newly elevated and expanded CFDA will integrate the functions of various agencies that regulate food, while also keeping its authority over drugs, devices, and cosmetics. At present, the primary focus has been on the consolidated regulation of food products, so the impact of these structural changes on the regulation of medical devices in China is unclear. Companies whose products are regulated by the agency should closely monitor the developments.
Source : http://www.sfda.gov.cn/WS01/CL0051/79254.html Publication Date : 2013-03-22