Guangdong-Tianjin-Hebei Pilot Free Trade Zone Enters 2.0 | Great Changes in Pharmaceutical Industry

Medicine Network May 28 hearing a big news these days.

On May 24, the State Council issued the "Proposal on Further Deepening the Reform and Opening-up of the China (Guangdong) Free Trade Pilot Zone," "To further deepen the reform and opening up program for the China (Tianjin) Free Trade Pilot Zone," and "to further deepen the China (Fujian) Free Trade Zone. Reform and opening up program.

The three-year Guangdong, Tianjin, and Handan-Zangshan Free Trade Zones entered the 2.0 phase. The programs in the three places have different contents related to medicine.

To allow the free trade zone, the medical device registration applicant entrusts the Guangdong medical device manufacturing enterprise to produce the product. Optimize the quarantine inspection process for biological materials and special articles for experimental bio-medicine research and development globally.

Innovate the regulatory model of the pharmaceutical industry. Optimize the licensing of special articles for experimental research and development of biopharmaceuticals worldwide. To comply with relevant national regulations drug Implementation of the priority review and approval batch. Support drug development agencies to participate in the trial of the drug market licensor system.

To allow medical device registration applicants in the pilot area to entrust Tianjin medical device manufacturers to produce products.

To support international cooperation in medical institutions in the FTA Pilot Zone, to introduce international multi-center clinical trials, and to carry out clinical trials of major new disease drugs simultaneously with foreign institutions. medicine Service Trade, Expand Chinese medicine Access to the international market for service trade promotes overseas innovation and development of Chinese medicine.

Deepen the integration of advanced manufacturing industries such as integrated circuits, optical instruments, and precision machinery, cold chain logistics, cultural innovation, healthy pensions, Chinese medicine and other modern service industries to Taiwan.

Supporting the employment in the free trade pilot area, the Taiwan compatriots living in the country enjoy the same treatment as the mainland residents in terms of medical treatment, financing, home purchase, accommodation, etc. Taiwanese enterprises enjoy the same treatment as mainland companies in terms of applications for research funding.

In the documents of Guangdong and Tianjin, there are 'approved applicants for registration of medical devices in the Pilot Free Trade Zone, and entrust Guangdong (Tianjin) medical device production. enterprise Production product's statement.

Combined with Shanghai's experience, it may be predicted that the era of medical device outsourcing has come. Since last year, with the approval of the State Council, the Shanghai Free Trade Zone has taken the lead in initiating reforms in the system of medical device registrants in the country. This has also triggered a major change in the industry.

Shanghai's reform allows products to be commissioned during the incubation period, allowing registrants to commission more production, allowing trustees that do not have production qualifications to submit registrant medical device registrations to apply for production licenses. The effect is obvious, Shanghai Minimax and Medtronic are effective. The enterprise has great achievements.

In terms of drugs, the contents of the documents in Tianjin are relatively numerous. For example, 'Approved for the review and approval of drugs that meet the relevant regulations of the country. Supporting drug R&D institutions to participate in the trial of the drug market's licensor system. ' 'Supporting the medical institutions in the free trade zone.' Developing international cooperation' etc.

With reference to Hainan's precedent, the big change is that imported drugs will come in more and faster. If Hainan's 'Boao Lokcheng International Medical Tourism Pioneer District' is approved for use, there are no products of the same category that are allowed to register in China. Drugs and medical devices. In addition, 'Drug and Drug R&D Institutions Participate in Pilot Licensing of Drugs Market' is even more straightforward.

Once again, China has declared to the world that the door to openness will not be closed. It will only grow bigger and bigger. For the pharmaceutical industry, this is a test of fairness: Competent companies can embrace the markets of the world and they are in a bad position, or they can accelerate progress. , or it will be replaced by the incoming product.