Global Pharmaceutical Innovation: Adhere to Open Development, Win-win Cooperation

The "14th Five-Year Plan" emphasizes the adherence to open development, win-win cooperation, and an active response to global pharmaceutical innovation. The new situation of the reshaping of industrial chains, industrial chains and supply chains, deepen international industrial cooperation, accelerate the cultivation of new competitive advantages, and integrate into the global innovation network and industrial system at a higher level.

Attract global pharmaceutical innovation elements to gather in China

Based on the large domestic pharmaceutical market, attract global innovative drugs and medical devices to take the lead in registering in my country, and overall shorten the time difference between domestic and international launch of innovative products. Support domestic clinical research institutions to actively participate in and organize international multi-center clinical research, and improve the international level of clinical research. Encourage multinational companies to set up R&D centers and innovative drug production bases in China. Guide domestic enterprises to introduce foreign advanced technology through cooperative development, technology licensing, etc., improve innovation efficiency, and narrow the gap with the international advanced level. Give full play to the policy advantages of Hainan Free Trade Port, and provide convenience for the clinically urgently needed licensed medical devices that have been listed abroad and have not been listed in China.

Promote domestic pharmaceutical companies to enter the international market at a higher level

Support enterprises to carry out simultaneous registration of innovative drugs at home and abroad, carry out global multi-center clinical research for developed country markets, and realize the value of innovative drugs in a broader space. Seize the opportunities in the international market for biosimilars, encourage vaccine manufacturers to carry out international certification, and produce and export vaccines in accordance with international vaccine procurement requirements. Increase the number of generic drug registrations in developed countries, and increase the proportion of first-time generic drugs, complex preparations and other high value-added products. Accelerate the global layout of the industrial chain, encourage enterprises to improve their international market operation capabilities, strengthen investment cooperation with countries jointly building the "Belt and Road", and actively explore emerging pharmaceutical markets.

Consolidate the foundation of international pharmaceutical cooperation

Strengthen international drug administration cooperation, deeply participate in international regulatory coordination mechanisms, play an important role in the formulation of relevant guidelines of the International Organization for Harmonization of Pharmaceuticals for Human Use (ICH), actively promote participation in the International Drug Inspection Cooperation Program (PIC/S), promote Domestic and foreign laws and regulations, mutual recognition of standards and mutual trust in quality. By promoting drug regulatory cooperation and mutual recognition with key regions, it will create conditions for pharmaceutical products to enter the international market more easily. Strengthen exchanges and cooperation with the International Herbal Medicine Regulatory Cooperation (IRCH), and play a leading role in the global leadership of traditional Chinese medicine standards. Promote domestic and foreign industry organizations to strengthen exchanges and cooperation in trade promotion, information exchange, industry self-discipline, and response to friction, and build a public service platform for international cooperation in medicine. Pay attention to the opportunities brought by the R&D capability, engineering scale-up capability and production capability improvement of the innovative drug sector.