From Wikipedia,
the free encyclopedia
The State Food and Drug
Administration of
China is founded on the
basis of the State Drug
Administration. The State Food and
Drug Administration is directly
under the State Council, which is
in charge of comprehensive
supervision on the safety
management of food, health food
and cosmetics and is the competent
authority of drug regulation.
Main Responsibilities
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. To be in charge of drug
registration, draw up, revise and
promulgate national standard of
drugs; draw up criteria for
marketing authoriazation 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 national essential
medicines list.
8. To draft and revise good
practices for drug research,
manufacturing, distribution and
use, and supervise their
implementation.
9. 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.
10. To regulate radioactive
pharmaceuticals, narcotics,
toxics, psycho -tropics, and other
controlled drugs and devices in
accordance with law.
11. To draw up and improve
qualification system for licensed
pharmacist, supervise and direct
the registration of licensed
pharmacist.
12. To direct national drug
regulation and comprehensive
supervision on the safety
management of food, health food
and cosmetics.
13. To carry out exchanges and
cooperation in drug regulation,
relevant safety management of
food, health food and cosmetics
with foreign governments and
international organizations.
14. To undertake other work
assigned by the State Council.
