|
 The
State Food and Drug Administration (SFDA) of China is restructured from
the previous State Drug Administration. The State Food and Drug
Administration is directly under the State Council of the People's
Republic of China, in charge of comprehensive supervision on the safety
management of food, health products and cosmetics products, and is the
sole and competent authority of drug regulation and administration in
mainland China.
Main Responsibilities of FDA
To organize relevant authorities to draft laws and
regulations on the safety management of food, health food and cosmetics;
organize relevant authorities to formulate comprehensive supervision
policy, work plan and supervise its implementation.
To exercise comprehensive supervision on the safety
management of food, health food and cosmetics in accordance with laws;
organize and coordinate supervision work on the safety of food, health
food and cosmetics carried out by relevant authorities.
To organize and carry out investigation and impose
punishment on serious safety accidents of food, health food and
cosmetics; delegated by the State Council, organize, coordinate and
conduct specific law-enforcement campaigns over safety of food, health
food and cosmetics nationwide; organize, coordinate and collaborate with
relevant authorities in carrying out emergency rescue work on serious
safety accidents of food, health food and cosmetics.
To comprehensively coordinate the testing and evaluation
for the safety of food, health food and cosmetics; formulate provisions
on releasing of supervision information for safety of food, health food
and cosmetics in conjunction with relevant authorities and monitor their
implementation; sum up safety information of food, health food and
cosmetics from relevant authorities and release it to the public
regularly.
To draft law and administrative regulations on drug
administration and supervise their enforcement; carry out protection
system for certain traditional Chinese medicinal preparations and
administrative protection system for pharmaceuticals in accordance with
law or regulations.
To draft law and regulations on administration of
medical devices and supervise their enforcement; take charge of
registration and regulation of medical devices; draft relevant national
standards, draw up and revise professional standards of medical devices,
manufacturing practice and supervise their implementation.
To be in charge of drug registration, draw up, revise
and promulgate national standard of drugs; draw up criteria for
marketing authorization of health food; review and approve health food;
set up classification system for prescription drugs and OTC drugs;
establish and improve ADR monitoring system; be responsible for drug
reevaluation, review drugs to be withdrawn and formulate a national
essential medicines list.
To draft and revise good practices for drug research,
manufacturing, distribution and use, and supervise their implementation.
To control the quality of drugs and medical devices in
manufacturers, distributors and medical institutions; release national
quality bulletin on drugs and medical devices on a regular basis;
investigate and punish illegal activities of producing and selling
counterfeit and inferior drugs and medical devices in accordance with
law.
To regulate radioactive pharmaceuticals, narcotics,
toxics, psycho -tropics, and other controlled drugs and devices in
accordance with law.
To draw up and improve qualification system for licensed
pharmacist, supervise and direct the registration of licensed
pharmacist.
To direct national drug regulation and comprehensive
supervision on the safety management of food, health food and cosmetics.
To carry out exchanges and cooperation in drug
regulation, relevant safety management of food, health food and
cosmetics with foreign governments and international organizations.
To undertake other work assigned by the State Council.
The State Food and Drug Administration is not
responsible for regulating pharmaceutical ingredients manufactured and
exported by chemical companies. This regulatory hole, which has resulted
in considerable international news coverage unfavorable to China, has
been known for a decade, but failure of Chinese regulatory agencies to
cooperate has prevented effective regulation. |
