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Hainan has optimized its policy allowing the import of urgently needed drugs and medical devices in the Boao Lecheng International Medical Tourism Pilot Zone. On March 28, , the Hainan government issued new guidelines regarding the administration of urgently needed imported drugs and medical devices in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port. The new guidelines optimize existing policies that came into effect in These drugs and devices have been authorized for sale abroad but have not yet received registration approval in China, or there are no equivalent products registered in China that can be used as a substitute. Importantly, these urgently needed imported drugs and medical devices must only be used for specific medical purposes in designated medical institutions. These institutions are responsible for ensuring their safe use and bear the main responsibility for associated safety risks. Moreover, in case the real-world data produced by these urgently required imported drugs and medical devices satisfies the criteria for drug and medical device registration and declaration in China, the applicants can include the data in their application documents for national registration. The application and approval process for urgently needed imported medical products in Hainan involves several steps and requirements outlined in the new regulations. First, the designated medical institution must meet specific criteria, such as holding a medical institution practicing license, having the capabilities of a tertiary Grade A hospital, and having professional departments suitable for the clinical use of urgently needed imported drugs and medical devices. The medical institution must also have protection measures and management systems in place for circulation, transportation, and storage that meet the requirements of the clinical urgently needed imported drugs and medical devices being applied for. Once a medical institution meets the criteria, it can apply for a qualification assessment review from the provincial health authority responsible for evaluation. If approved, the medical department or team that intends to use the product must hold a valid practice license and have sufficient knowledge of the product to use it correctly and reasonably. The designated medical institution must then submit an application for use through the Clinical Urgently Needed Imported Medical Products Traceability Management Platform, ensuring that the application materials are legal, accurate, and traceable. The provincial drug supervision and administration department should complete the assessment within seven working days of receiving the application. These guidelines outline the roles and responsibilities of various entities, such as provincial health and drug regulatory departments, medical institutions, and pharmaceutical enterprises. Provincial health and drug regulatory departments must manage the importation, circulation, and use of these devices, assess associated risks, prevent illicit drug flow, and ensure proper control of drugs with special management requirements. Medical institutions designated to use these devices are responsible for their proper use and disposal, while pharmaceutical enterprises must follow relevant regulations for purchasing, storing, and distributing these devices. If a patient is harmed due to the use of an urgently needed imported medical device and drugs, the designated medical institution must accept liability and provide appropriate compensation. The guidelines also recommend that designated medical institutions purchase medical commercial insurance to protect against unforeseen events. Failing to comply with these regulations will have repercussions for medical institutions. By participating in the program, overseas manufacturers can expand their business and increase their revenue by providing high-quality and in-demand products to Chinese consumers. Additionally, the program provides an opportunity for overseas manufacturers to establish partnerships and collaborations with Chinese companies, further enhancing their competitiveness and market reach. The zone has sought to attract commercial investment and cooperation with foreign institutions, including international hospitals, testing laboratories, medical colleges, and tourism institutions, to attract both domestic and international patients. To achieve this goal, the Beijing government has implemented various preferential policies to upgrade the medical techniques, devices, and drugs available at the Pilot Zone and meet international standards by Over 20 medical institutions have already opened here, and 10 more specializing in fields like cancer prevention and treatment, cosmetic medicine, anti-aging, health management, and rehabilitation are set to join. The establishment of the Hainan Free Trade Zone FTZ is expected to further boost the medical tourism zone project and leverage market opportunities created by the growing demand for medical products and services. With significant investments made towards developing the healthcare industry in the region, Hainan is on track to becoming a world-class medical tourism destination and medical technology innovation center by Foreign investors can leverage the favorable tax policies, incentives, and advantages available in Hainan to invest in various healthcare sectors, such as international hospitals, third-party testing institutions and laboratories, medical colleges, pension insurance companies, and medical tourism institutions. By doing so, they can capitalize on the increased demand for medical products and services and contribute to the growth of the healthcare industry in the region. Please contact the firm for assistance in China at china dezshira. Meet the firm behind our content. Visit their website to see how their services can help your business succeed. Subscribe to receive weekly China Briefing news updates, our latest doing business publications, and access to our Asia archives. 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In addition to travel is to buy and buy? Hainan is also good for innovative drugs! These listed enterprises have been approved · $Nuocheng Jianhua-B (HK) $.
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What can everyone think of when talking about Hainan? Tropical sunshine? Sea, beach, coconut trees? Or is it a duty-free shop that tourists keep buying? In fact, in the field of innovative drugs, Hainan is also a rising star, attracting more and more attention from world-renowned pharmaceutical companies, Chinese innovative pharmaceutical companies and pharmaceutical investors. Advance area of international medical tourism Where the value and prospects lie. Just as Shenzhen is a special economic zone in China, it enjoys many preferential economic policies, and the Lecheng International Medical Tourism advance Zone is the only 'medical special zone' in China. It enjoys a series of special policies such as 'licensed medical treatment, franchised research, franchising, franchised international medical exchange' and real-world data pilot. Specifically, 'licensed medical treatment' refers to the licensed access to medical technology, medical devices and drugs, and the registration of overseas doctors has been relaxed to three years. Among them The policy of concessionary access for medical technology, medical devices and drugs allows the Lecheng advance area to enjoy the 'small and urgent' licensed pharmaceutical equipment import policy granted by the state, and the right to examine and approve clinically urgently needed imported medical devices and drugs. As long as the doctor, patient or manufacturer applies for a new drug, a selection meeting will be held to explain the product when the first case is used, and the drug review will be organized by the Hainan Provincial Drug Administration Bureau, which mainly includes the past registration and use data of the drug; if there is an application for use in the follow-up use process, there is no need to hold a selection meeting, directly in the form of electronic reply to ensure that patients re-use the new drug as soon as possible. In addition, in view of the fact that all medical devices imported by enterprises in the leading area are in urgent clinical need and high time-effectiveness requirements, Haikou Customs only inspects the outer packaging of imported drugs and equipment in principle and releases them as soon as they comply with the regulations. At the same time, to achieve the networking of 40 kinds of regulatory documents, comparison and verification in the customs clearance link, the customs no longer requires enterprises to submit paper certificates and paper endorsements, further streamline customs clearance procedures, and reduce the customs clearance costs of enterprises. For the clinically urgently needed imported drugs excluding vaccines and pharmaceutical equipment to be used in the advance area, they can enter the bonded warehouse in batches before obtaining approval, and then write off the warehouse according to the actual use. Due to the differences in the ultra-long approval process and regulatory system, the non-mutual recognition of drug clinical data has always been a key pain point in the development of innovative drugs, and it is also one of the main risks faced by innovative pharmaceutical companies. Now, a series of policies in the advance area can solve these pain points to a great extent and speed up the entry of innovative drugs into China. At present, the new products of a number of international pharmaceutical giants and Chinese innovative pharmaceutical companies have been used for the first time in the advance area. Recently, the innovative drugs of these enterprises have been approved for use in the advance area. Nuocheng Jianhua said on July 22nd that according to the pilot project of Boao Le City International Medical Tourism pilot area, the treatment of Tafasitamab combined with lenalidomide has been approved by the Hainan Provincial Health Commission and Drug Administration to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma 'relapsed and refractory DLBCL' who are not suitable for autologous stem cell transplantation 'ASCT'. Tafasitamab is a humanized monoclonal antibody targeting Fc domain optimization of CD The drug is expected to be used in patients with locally advanced or metastatic non-small cell lung cancer NSCLC with positive RET gene fusion in mainland China, adults with advanced or metastatic medullary thyroid carcinoma MTC with RET mutations requiring systematic treatment, and children aged 12 and above. Positive RET gene fusion requires systematic treatment and radioiodine therapy if applicable for advanced or metastatic thyroid cancer in adults and children aged 12 years and older. Septini was included in the priority review by the Drug Review Center of the State Drug Administration of China CDE in August and is looking forward to being officially approved for listing on Chinese mainland in the future. PharmaMar , has been approved by Hainan Provincial Drug Administration to be imported and can be used in clinical urgent need in specific medical institutions in Lecheng International Medical Tourism advance area. Lurbinectedin, a selective oncogene transcriptional inhibitor, was approved by the Food and Drug Administration FDA in for the treatment of recurrent small cell lung cancer SCLC adult patients with recurrent small cell lung cancer SCLC during or after platinum chemotherapy. In addition to the United States, the drug has received temporary marketing approval in Australia, the United Arab Emirates, Canada, Singapore and Qatar for the treatment of recurrent SCLC adults who develop disease during or after platinum chemotherapy. The neutralizing antibody Evusheld imported by Chinese mainland for the first time has completed the examination and approval of entry special items, and Ruijin Hainan Hospital and Boao Super Hospital began to use drugs for the first batch of appointments on July 9. According to information disclosed by manufacturer AstraZeneca PLC, previous clinical trials have shown that the risk of COVID 's symptoms in patients treated with Evusheld is statistically significantly lower than that in placebo, and the protective effect of the virus lasts for at least six months, although longer follow-up is needed to determine the duration of complete protection provided by Evusheld. For the current global popularity of the Omicron mutant, data show that Evusheld still has protective effect against many subtypes of Omicron, including BA. Soochow Securities said The pharmaceutical sector is cost-effective, and the excess income in the second half of the year will be more obvious. The innovative drug sector has experienced a long and substantial pullback since the second half of , and the valuations of many high-quality innovative drug standards have been in the bottom range. The XBI index of US stocks has also rebounded recently, and premium biotech stocks have regained their attention. In the long run, the commercial ceiling of innovative drugs is high enough, and the relevant direction is worthy of attention. As the only 'medical special zone' in China, Lecheng leading area is expected to become an important weather vane for the future development of innovative drugs. Use the share button in your browser to share the page with your friends. Hainan is also good for innovative drugs! The translation is provided by third-party software. The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it. Got it. Risk Disclaimer. This page is machine-translated. Futubull tries to improve but does not guarantee the accuracy and reliability of the translation, and will not be liable for any loss or damage caused by any inaccuracy or omission of the translation. Write a comment. Tap here to share. No comments yet. Write one.
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