On May 12th, the 6th Annual DIA China Conference organized by the Drug Information Association and the China Food and Drug International Exchange Center was held in Shanghai. The theme of the conference was: Quality and Compliance - Meeting Patient Needs The guarantee.

Yin Li, deputy director of the State Food and Drug Administration pointed out at the conference that the Chinese government attaches great importance to the development of the pharmaceutical industry and drug supervision. In 2013, the Chinese government established the State Food and Drug Administration to further optimize the allocation of regulatory resources and comprehensively strengthen food and drug safety supervision. After the establishment of the State Administration of Science and Technology, it focused on the special rectification of drug safety, and on the one hand, it promoted the reform of pharmaceutical supervision and strived to achieve both the symptoms and the symptoms of the drug problem.

By the end of 2013, 796 sterile drug manufacturers passed inspections. From January 1st, 2014, all non-certified aseptic pharmaceutical manufacturers stopped production (about 40% of the total number of companies), guaranteed a standard, a rule, and there are no exceptions.

More than 1200 pharmaceutical manufacturing enterprises of other categories have passed the newly revised GMP certification for pharmaceuticals and promoted the improvement of internal quality management systems, effectively improving the quality management level and risk control capabilities of the company. In addition, the implementation of the newly revised Drug GSP was initiated, and five supporting documents for the newly revised Drug GSP implementation were formulated.

Yin Li pointed out that the State General Administration will continue to make every effort to promote the establishment of the most stringent drug safety supervision system, advance the construction of a quality safety traceability system, regulate the development of pharmaceuticals from research and development, production and sales to the use of full chain management, accelerate the revision of laws and regulations, and enhance enterprise maintenance. The responsibility for drug quality will further enhance the level of drug supervision. In the coming period, we will focus on the following tasks:

The first is to speed up the legislative process and improve the system of laws and regulations. The revision of the "Drug Administration Law" and related supporting documents will be promoted, and prominent problems and system deficiencies existing in the current drug supervision work will be actively solved, and the work of laying the foundation and establishing norms shall be done. We must speed up the construction of management systems for drug flight inspections, overseas drug production inspections, and issuing batches of biological products, and continue to do a good job in the supervision and implementation of newly revised pharmaceutical GMPs and GSPs.

The second is to unswervingly promote the review and approval of drugs. Further reduce the administrative examination and approval issues of the State Administration of Administration, and entrust some provincial drug administrations with the entrustment of the provincial bureaus, and gradually realize the pattern of review, approval, and approval of SLA and provincial bureaus; and draw lessons from international experience to research and improve the drug review fee policy. With the government buying services, efforts have been made to resolve outstanding problems in the current shortage of drug reviewers and improve the efficiency of review and approval.

The third is to continue to strictly punish violations of laws and regulations, high-pressure situation. We will focus on the special rectification of the production and sale of counterfeit and inferior drugs, illegal marketing of drugs on the Internet, and illegal advertisements. Strengthen administrative law enforcement and criminal justice cooperation in the investigation of cases, information, technical support, legal protection and other aspects, and severely crack down on criminal activities in the field of drugs.

The fourth is to accelerate the informationization of drug supervision. Make use of the Internet and electronic technologies to do a top-level design of the informationization of drug supervision, promote the construction of an information platform for drug supervision in China, provide platform support for the formation of regulatory cooperation between the central and local authorities, and realize the full flow of drugs. The supervision of breeds lays the foundation for creating conditions for improving the efficiency of drug safety supervision.

The fifth is to strengthen international exchanges and cooperation in the regulatory field. Actively introduce new knowledge, new technologies, understand the experience or lessons of global peers, continue to strengthen the supervision team, strengthen communication and exchanges with the world, deepen sharing and cooperation, develop steadily in learning and sharing, and jointly meet the needs of patients, protect Patient rights.