Hainan Provincial Drug Administration Functional Information
Main responsibilities:
(a) to formulate and organize the implementation of the province's drug supervision and management work development strategy and policy measures, drafting relevant draft laws and regulations, study and put forward to promote the province's drug supervision and management reform opinions and recommendations.
(B) is responsible for the supervision and management of the province's drugs (including traditional Chinese medicine, ethnomedicine, the same below), medical devices and cosmetics safety. Supervise the implementation of national drugs, medical devices and cosmetics laws and regulations. Formulate management and service policies to encourage new technologies and products of drugs, medical devices and cosmetics.
(C) is responsible for overseeing the implementation of national drugs, medical devices and cosmetics standards. Organize and implement the protection system of traditional Chinese medicine varieties and drug classification and management system; formulate and supervise the implementation of the province's local standards for Lebanese medicines, Chinese herbal medicines and marine medicines; revise and formulate the province's quality standards for Chinese herbal medicines and traditional Chinese medicinal herbs, technical standards and specifications for the preparation of medical units. Audit the province's national essential medicines catalog, participate in the selection of essential medicines non-catalogue drugs and ethnic medicines, with the relevant departments to implement the national essential medicines system.
(D) is responsible for the province's drug and medical device registration management. Development of registration management system, strict listing review and approval, improve the review and approval of service facilitation measures, and organization and implementation. Responsible for domestic non-special-use cosmetics and the State Council gave the province imported non-special-use cosmetics record management.
(E) is responsible for the province's drugs, medical devices and cosmetics quality management. Supervise the implementation of pharmaceutical and medical device development, production, operation, use of quality management standards; supervise the implementation of national cosmetic production and management standards, responsible for the development and implementation of the province's cosmetic production and management supervision and management system.
(F) is responsible for the province's drugs, medical devices and cosmetics post-market risk management. Establishment of adverse drug reactions, medical device adverse events and cosmetic adverse reaction risk monitoring system, and carry out monitoring, evaluation and disposal. Responsible for drug, medical device and cosmetic safety incident emergency response system construction, organization and guidance of drug, medical device and cosmetic safety incident emergency response and investigation and treatment.
(VII) is responsible for the province's licensed pharmacist qualification access management. Supervise the implementation of licensed pharmacist qualification access system, organization and implementation of the registration of licensed pharmacists.
(H) is responsible for organizing and guiding the province's drugs, medical devices and cosmetics supervision and inspection. Responsible for the production of drugs, medical devices and cosmetics licensing, inspection and punishment, as well as drug wholesale licensing, retail chain headquarters licensing, Internet sales of third-party platforms for the record and inspection and punishment. Supervision and management of Chinese herbal medicine market. Supervision and management of narcotic drugs, psychotropic drugs, toxic drugs, radiopharmaceuticals, pharmaceutical chemicals. Responsible for drug and medical device advertising approval (for the record).
(IX) is responsible for carrying out the province's drugs, medical devices and cosmetics foreign exchanges and cooperation, safety publicity, education and training; to promote the province's drugs, medical devices and cosmetics inspection and testing system, traceability system, credit system construction.
(J) is responsible for organizing, formulating and supervising the implementation of the province's drugs, medical devices and cosmetics sampling plan, the release of drugs, medical devices and cosmetics quality bulletin. It establishes a system for recalling and handling problematic products and supervises its implementation.
(xi) Undertake the approval of imported medicines and medical devices of clinical urgency granted by the State Council to Boao Licheng International Medical Tourism Pioneer Zone, and be responsible for the daily supervision of medicines and medical devices, adverse drug reactions and risk monitoring of adverse medical device events in Boao Licheng International Medical Tourism Pioneer Zone.
(xii) Guiding the supervision and management of medicines, medical devices and cosmetics by market supervision and management departments of cities and counties.
(xiii) Completing other tasks assigned by the provincial party committee, provincial government and higher authorities.
