Medical network on July 14th - July 13, sponsored by the state food and drug supervision and management of administration, in collaboration with the Chinese medicine institute, henan to undertake at the food and drug administration of the "2017 bric countries drug regulatory cooperation conference" was held in zhengzhou. The reporter understands in the meeting, the state food and drug supervision and management of administration to strengthen and deepen the bilateral cooperation between the government, as of June 2017, total bureau has been to 66 countries establish daily work connection regulators, with 28 countries and regions have signed 42 bilateral cooperation documents.
State food and drug supervision and administration bureau deputy director wu in his speech, pointed out that since 2015, the brics alone drug regulatory cooperation meeting, since it provides a regular exchange platform for each other, reporting the latest regulatory policies and requirements, to seek supervision chain to connect with each other, seek common ground while putting aside differences, enhance mutual trust, achieve win-win cooperation, balanced development and mutual security. State food and drug supervision and management of administration are around the "win-win cooperation" "balanced development" and "common security" of the concept of international cooperation, continue to expand international exchanges and cooperation channels and areas, build platform, improve level, draw lessons from international advanced supervision idea and experience, enhance drug safety guarantee ability, promote international drug supervision work.
Drug regulatory internationalization
Conference, state food and drug supervision and management of the administration, kaohsiung Yuan Lin director introduces, administration of active participation in international organizations and multilateral rules and revising mechanism. First, after a long and hard negotiation, in June 2017, ICH meeting held in Montreal, Canada, administration official to membership of, for example, it is the international community the Chinese government for examination and approval of drug approval system reform and the development of medicine industry recognition, means China's regulators, the pharmaceutical industry and r&d institution formally joined the drug registration in the highest international rules and standards in the field of organization. Second, administration closely to carry out all-round cooperation with the world health organization (who), pass vaccine regulation capability assessment, promoting drugs vaccine and in vitro diagnostic reagent certification, to form a chemical drugs, biological products and traditional medicine cooperation center, and around the global benchmark assessment indicators, improve regulation ability, reached the international advanced level. Third, actively participates in international drug regulatory agency of alliance, medical apparatus and instruments regulators BBS, apec and other international organizations and multilateral rules work mechanism, and actively encourage scientific research institutions, colleges and universities, industry associations and media participation, aiming at to regulation, gradually achieve our drug regulations, standards, technical guidelines and methods of international coordination.
To consolidate and deepen the bilateral cooperation between the government of mechanism. First, innovative ideas, and related state food and drug regulator on an integrated, centralized and close cooperation mode, create Danish food and drug regulatory cooperation center in China, the bilateral cooperation project into effect. Second, continuous upgrading of the level of bilateral agreements and efficiency, we signed with the U.S. department of health and human services on medicines and medical equipment safety agreement; Graduates with Japan signed a memorandum on the consultation and cooperation mechanism; With the European Union health and consumer protection one signed the consultation and cooperation mechanism; The Chinese government signed with the Swiss federal council on food, drugs, medical equipment and cooperation agreement in the field of cosmetics, in the form of file information exchange, regulations, exchange and communication mechanism. Third, focus on personnel exchanges, watching examination, generic review share issues such as the regulation idea and experience, substantive to promote bilateral cooperation.
Administration of active international project introduction and capacity building. First of all, using the world health organization (who), the gates foundation, the world bank, the global fund, United Nations industrial development organization (unido) provide project funding, such as the introduction of international intellectual resources, strengthen their own capability and better serve the drug approval for examination and approval system reform in China. Second, giving full play to the advantages of demonstration projects, the choice in some parts of the key industries as the pilot, draw lessons from advanced experience, build a comprehensive security system with Chinese characteristics and drug safety. Third, actively send personnel to participate in international conferences and programs, and to the international organization, strengthen the cooperation and to solve the problem of key technology research.
Administration emphasis important drug safety events of international coordination. First of all, based on existing drug monitoring by the world health organization collaborating centre for information reporting system and multilateral cooperation agreement, to strengthen the communication with related international organizations and regulatory agencies. Secondly, perfecting our country's drug safety emergency contingency plans and foreign terms, timely and effective response to domestic and international events, realize information sharing. In addition, to strengthen the cooperation with international organizations and regulatory agencies, actively involved, timely communication, closely tracking, and invite international experts to deal with public opinion.
Build brics cooperation mechanism
According to the outcomes of the meeting, Yuan Lin said expectations as soon as possible to determine the brics cooperation memorandum of text, expanding consensus, seeking common ground while putting aside differences, to complete their approval procedure as soon as possible, strive to be completed during the brics leaders meeting signed, and formally set up the brics drug regulatory cooperation mechanism; Looking forward to establish a regular laws unblocked communication channels, reporting the latest progress of regulations amending, and organize regular industry oriented seminars, help related enterprises to understand the national regulatory and legal system; Encourage a platform, the supervision and inspection of the cooperation on the basis of the view to check each other, and selected excellent international inspectors, adopting internationally accepted inspection technology indicators, to conduct joint inspection and to realize the sharing of the corresponding inspection report; Suggestions to carry out the innovation drugs and generic drugs review pilot cooperation, ICH technical guidelines as the core, relying on the world health organization (who) certification system, explore the possibility of a joint review; Hope to develop brics countries in major international multilateral meetings before and after coordination, communication, mutual echo, and revising the rules of the international arena unity of sound, so as to expand international voice.
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