The Functional Transformation of the US Food and Drug Administration in Guangdong
(1) Cancel the tariff. 1. Gradually integrate the two administrative licenses of drug production and good manufacturing practice (GMP) certification into one administrative license. 2. Gradually integrate the two administrative licenses of drug trading (wholesale trading) and drug trading quality management standard (GSP) certification into one administrative license. 3. Integrate the change record of drug production quality authorized person into the administrative license of GMP certificate issuance and change. 4. Cancel the catalogue review of over-the-counter drugs, and pharmaceutical production enterprises put forward applications or suggestions for converting prescription drugs into over-the-counter drugs, and relevant materials are directly submitted to China Food and Drug Administration. 5. Cancel the overseas production record of protein assimilation preparations and peptide hormones. 6. Cancel the filing of the medical device registration applicant. 7. Cancel the examination and approval of clinical trials and clinical verification of Class II medical devices. 8. Cancel the duty of examination and approval for the registration of licensed pharmacists, which shall be undertaken by the trade association confirmed by the provincial US Food and Drug Administration. 9. Cancel the filing of anti-acne cosmetics. 10. cancel the quantitative classification of food safety in catering services. 1 1. Cancel the filing of the training institution for food safety administrators in catering services. 12. Cancel the filing of health examination institutions for catering service employees. 13. Other duties that need to be cancelled according to the requirements of institutional reform and functional transformation. (2) Decentralized responsibilities. 1. Decentralize the responsibility of issuing export sales certificates of drugs to the food and drug supervision and administration departments at the prefecture level. Involving the need to issue a certificate, the provincial food and drug administration shall support it. 2. Delegate the responsibility of issuing export sales certificates of medical device products to the food and drug supervision and administration departments at prefecture level and listed on the market. Involving the need to issue a certificate, the provincial food and drug administration shall support it. 3. Delegate the business license responsibilities of Class II and Class III medical devices to the food and drug supervision and administration departments at the prefecture level or above. 4. Decentralize the GSP certification responsibility of pharmaceutical retail enterprises to the food and drug supervision and administration departments at prefecture level. 5. Delegate the responsibility of issuing transportation certificates of narcotic drugs and psychotropic drugs of category I to the food and drug supervision and administration departments at the prefecture and municipal levels. 6. Entrust the responsibility of issuing the mailing certificate of narcotic drugs and psychotropic drugs to the food and drug supervision and administration department at the prefecture level. 7. Decentralize the responsibility of issuing export sales certificates of health food to the food and drug supervision and administration departments at prefecture level and listed on the market. 8. Decentralize the responsibility of health food business license to the food and drug supervision and administration department at the prefecture level. 9. Decentralize the supervision responsibility of the professional market of Chinese herbal medicines to the food and drug supervision and management departments listed at the prefecture level. 10. Other responsibilities that need to be delegated according to the requirements of institutional reform and functional transformation. (3) transfer responsibility. 1. The provincial health department shall draft local regulations on drugs and medical devices, formulate relevant standards and technical specifications according to law, and distribute them to the provincial US Food and Drug Administration. 2. The responsibility of the Provincial Health Department to formulate the qualification conditions and inspection specifications of food safety inspection institutions is assigned to the provincial US Food and Drug Administration. 3. Assign the responsibility of the Provincial Administration for Industry and Commerce to supervise and manage the food safety in circulation to the provincial US Food and Drug Administration. 4. The responsibilities of quality and safety supervision and management of food production and processing, administrative licensing of cosmetics production and compulsory inspection of food and cosmetics of the Provincial Bureau of Quality Supervision were assigned to the provincial US Food and Drug Administration. 5. Transfer the duties of supervision and management of alcohol circulation of the Provincial Economic and Information Technology Commission to the provincial US Food and Drug Administration. 6. Other responsibilities that need to be transferred according to the requirements of institutional reform and functional transformation. (4) Increased responsibilities. 1. Certification of quality management standards for drugs and medical devices. 2. Supplementary application for drug re-registration and administrative license without changing the internal quality of drugs. 3. Under the premise of not changing the internal quality of products, apply for the administrative license for the change of domestic third-class medical devices. 4. The administrative license for the entrusted production of drugs originally under the responsibility of the state. 5. Non-special purpose cosmetics import administrative license. 6 new drug technology transfer and drug production technology transfer administrative license. (5) Strengthen responsibilities. 1. Change management concepts, innovate management methods, promote the shift of work focus from pre-approval to post-supervision, give full play to the role of market mechanism, social supervision and industry self-discipline, and establish an effective mechanism for producers and operators to become the first responsible person for food and drug safety. Explore the application of credit records and credit reports in food and drug supervision. 2. Strengthen the construction and comprehensive coordination of the food safety system, improve the drug standard system and quality management norms, optimize the drug registration and related administrative licensing management processes, improve the food and drug risk early warning mechanism and the supervision and inspection mechanism of cities, counties and towns, and build a regional and systematic food and drug safety risk prevention mechanism. 3. Steadily promote the integration of food and drug inspection and testing institutions, treat social forces fairly to provide inspection and testing services, increase the government's efforts to purchase services, improve the technical support and security system, and improve the scientific level of food and drug supervision and management. 4. Standardize food and drug administrative law enforcement, improve the effective linkage mechanism between administrative law enforcement and criminal justice, and promote the punishment of food and drug safety violations according to law. Increase the information disclosure of food and drug supervision and punishment.