Hainan gets the right to approve imported medical devices | Leading companies in innovative drugs will benefit
Medical Network April 10 News April 8, the State Council issued "on the suspension of the implementation of international medical tourism in Boao Music City Hainan pre-emptive implementation <医疗器械监督管理条例>The decision on relevant regulations formally granted Hainan Province the authority to approve some imported medical devices, that is, medical devices that are urgently needed for medical institutions in the predecessor region and have not yet been registered for the same type of products in China. The Hainan provincial government implements the import approval. Use in designated medical institutions.
As early as in 2013, Hainan Province received the “State Council's approval to establish Hainan Boao Music City International Medical Tourism Pilot Area”, which includes: Accelerating the import and export registration and registration of medical devices and drugs in the pioneer zone; The pre-emptive zone can be based on its own technical capabilities. To apply for research on cutting-edge medical technology research projects such as stem cell clinical research; to appropriately lower the import tariffs on some medical devices and medicines in the foregoing region; to encourage the use of multiple channels for financing in the pioneer area to attract social investment, etc.
The most critical and most critical part of these policies is that, for medicines and medical devices that have been approved for listing in the United States, Japan, and the European Union, before the country approves the introduction, it can be introduced first by the preemption zone. The problem to be solved is that People who use vaccinations, beauty treatments, and the latest anti-cancer drugs can go overseas without going abroad, but they can come to Boao. 'The Hainan Governor Shen Xiaoming told the media last month that the nine-valent HPV vaccine for preventing cervical cancer will Took the lead in 'playing' in Boao, and many people have ordered the vaccine through different channels.
According to relevant persons from the music city's predecessor area management committee, Hainan Province has been continuously improving the efficiency of new drug imports. First, the introduction of pharmaceutical production such as Sinopharm Holdings. enterprise , Pharmaceutical companies establish channel relationships. The second is to establish Boao Public Bonded Drug Stores, to serve the entire pre-emptive area with the policy of “Domestic customs and customs”, to prepare drugs in advance, and to obtain pharmaceuticals at any time after the medical institutions in the district first obtain approvals. The predecessor area submitted the application to the National Bureau (CDFA), and the National Bureau formally promised to reply within 5 working days.
It is reported that on March 31st Boao 'Super hospital On the opening day, the company commissioned the company to import the first 10 sets of cochlear implant systems worth US$430,000.
According to industry sources, allowing early-stage trials of new drugs outside China and encouraging the submission of research on cutting-edge medical technologies such as stem cell clinical research will greatly stimulate the innovation and research and development of domestic pharmaceutical companies. Livzon Group, Fosun Pharmaceutical, Hengrui Pharmaceutical and other innovative pharmaceutical companies The part of it has obtained FDA certification drug It is expected to be used in the predecessor area and related companies are expected to benefit.
March 6, Hainan medicine Industry associations organized companies to visit Boao Lecheng pre-provincial area to help pharmaceutical companies to better understand the local preferential policies, investment environment and medical and health industry planning layout. Listed company Jiuzhitang, Shuangcheng Pharmaceutical, Hainan Haipharm, Xinsanban Huanglong Pharmaceutical Co., Ltd. 18 other pharmaceutical companies participated in the inspection.
Among them, the staff of Hainan's local pharmaceutical company Shuangcheng Pharmaceuticals told reporters that the development of Boao Lok City International Medical Tourism Pioneer Zone is an opportunity for the company, but it needs the company to do a good job in related development strategy planning. The double pharmaceutical industry has been for many years Persisting in internationalization, from the production of raw material medicines to the production of lyophilized preparations, relevant production lines or production workshops have passed and GMP certifications by the European Union or the United States have been completed. At the same time, the staff mentioned that this is also an opportunity for the related pharmaceutical cold chain logistics industry.
According to Shuang Yuqing, Chairman of Beixiang Investment Group, the landing of relevant policies is the first step to opening Hainan's demonstration effect. Next, supervision and setting up emergency measures are urgent issues. As an investor, he said, Most of the enterprises in the pilot area are not yet mature and have certain limitations. They will be more cautious when investing, and the scale of investment will be mainly pilot scale. However, he also stated that he will still seize the opportunity and actively introduce foreign companies or products to settle in Hainan. , to establish experimental and developmental companies, to create market influence at the same time, and to cultivate more medicines that can smoothly pass the formal approval of the State Bureaux and be fully listed in the country or medical instruments.
