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The major duties of the Shanghai Municipal Food and Drug Supervision
Administration are:
1. To implement the national guidelines, policies, and laws, rules and
regulations relating to safety administration of food, health products and
beauty products and supervisory administration of drugs; to organize the
relevant departments to study and draw up the drafts of the local rules and
regulations on the safety administration of food, health products and beauty
products in the light of the actual circumstances of this Municipality; to
formulate the comprehensive supervisory policies and working planning, and
supervise the implementation of such local policies and planning; to study and
draw up the drafts of the relevant local rules and regulations on supervisory
administration of drugs and administration of medical instruments; and formulate
the relevant supporting policies.
2. To fulfill the comprehensive supervision duties over the safety
administration of food, health products and beauty products in this
Municipality, and to organize and coordinate the safety supervision work of
food, health products and beauty products assumed by the relevant departments;
to organize and coordinate the implementation of special item law enforcement
supervisory activities concerning the safety of food, health products and beauty
products according to the authorization of the Municipal Government; to organize
and conduct the investigation and handling of major safety accidents and cases
of food, health products and beauty products according to law; to organize,
coordinate and cooperate with the relevant departments to carry out the
emergency aid in major safety accidents of food, health products and beauty
products
3. To coordinate the test and determination, and evaluation of the safety of
food, health products and beauty products in a comprehensive manner; to
formulate the supervisory information releasing procedures related to the safety
of food, health products and beauty products jointly with the relevant
departments, and to supervise the implementation of such procedures; to
integrate the safety information of food, health products and beauty products
from the relevant departments, and to release periodically such information.
4. To be responsible for the initial examination of new drugs, imitation
drugs, protective varieties of Chinese traditional medicines, eliminated drugs,
packing materials for drugs, and health products; to organize the carry-out of
the OTC system; to examine the export drugs; to be responsible for the
re-assessment of drugs and the monitor of the untoward reaction of drugs; to
examine and approve the drug advertisements.
5. To supervise the implementation of the legal standard for medical
instrument products; to examine and approve the registration of medical
instrument products; to be responsible for the re-assessment and the monitor of
the untoward reaction of medical instrument products; to examine and approve the
medical instrument advertisements
6. To supervise the implementation of the quality administration norm and
authentication system of production and business operation of drugs and medical
instruments and their preparation production by the medical units; to organize
the authentication of drug production and quality management norm of operating
enterprises according to law; to be responsible for the approval and issuance of
permits for production and business operation enterprises of drugs and medical
instruments as well as preparation production by the medical units
7. To be responsible for preliminary examination and recommendation of drugs
of non-clinic research institutions and clinic research bases; to supervise the
implementation of administrative norms for drugsĄ¯non-clinic research and clinic
tests; to be responsible for the examination and approval of medical instrument
clinic test units; to be responsible for administration of the drugs and medical
instrument inspection institutions; to conduct the affirmation of qualification
of the quality of medical instrument inspection institutions; and those that
involve metrological authentication shall be enforced according to the relevant
regulations.
8. To supervise and control the narcotics, psychotropic drugs, toxic drugs,
drug-relief medicine, radiopharmaceuticals, and special medical instruments
according to law.
9. To be responsible for the supervision and inspection of the quality of
drugs and medical instruments; to be responsible for the release of quality
bulletins of drugs and medical instruments; to investigate and punish the
production and sales of counterfeit and poor quality drugs and medical
instruments and other law-violating acts according to law.
10. To be responsible for the registration of practicing pharmacists; to
organize the implementation and supervisory administration of practicing
pharmacists qualification system jointly with relevant departments.
11. To carry out the exchange and cooperation with foreign governments as
well as international organizations concerning drugs supervision and
administration, and the safety administration of food, health products and
beauty products.
12. To be responsible for the acceptance and handling of administrative
reconsideration cases and response to administrative actions.
13. To undertake other matters assigned by the Municipal
Government. |
