"people wait for medicine" becomes "medicine waits for people", beijing introduces new policies to improve the accessibility of medicines for rare diseases
2024-09-21
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on september 20, the beijing municipal people's government information office held a press conference on the progress of tasks in the medical and health sector in the construction of beijing's "two districts".
reporters learned from the meeting that beijing has introduced two innovative policies to improve the accessibility and convenience of drugs for rare diseases and drugs and medical devices urgently needed in clinical practice; introduced two drug review and approval reform measures, implementing the "supplementary application review period reduced from 200 days to 60 days" pilot and the "drug clinical trial approval period reduced from 60 days to 30 days" pilot to accelerate the review and approval of innovative drugs and medical devices; and issued the "beijing work plan to promote drug exports" to help drugs and medical devices "go overseas."
drugs for rare diseases can be cleared once and used multiple times outside the region
cao wei, director of the beijing municipal drug administration, introduced that the "work plan to support beijing in deepening the construction of a national comprehensive demonstration zone for expanding the opening-up of the service industry" proposed supporting the establishment of a pilot zone for rare disease drug security in the beijing tianzhu comprehensive bonded zone, exploring the import of rare disease drugs that have not been registered and marketed in the country, and guiding the use of drugs by specific medical institutions; and establishing a green channel for the approval of imported drugs and medical devices urgently needed in clinical practice in beijing.
against this background, beijing has issued the "beijing implementation plan (trial) for promoting the construction of a pilot zone for rare disease drug security" and the "beijing implementation plan (trial) for promoting the import of clinically urgent drugs and medical devices".
cao wei said that as early as three years ago, the country had clarified the relevant systems and work processes for temporary import applications, use management, etc. for clinically urgently needed drugs, and successively imported rare disease drugs such as clobazam used by peking union medical college hospital to treat rare or refractory epilepsy and vosoritide used by beijing children's hospital to treat achondroplasia. the two implementation plans issued by beijing this time, based on the previous work, further optimize the supply guarantee mechanism for rare diseases and clinically urgently needed drugs and equipment by building pilot areas and optimizing work processes, shorten the waiting time for patients to take drugs, ensure the number of varieties, and achieve full traceability.
among them, the construction of the green channel for the approval of the import of drugs and medical devices urgently needed in clinical practice focuses on "speed" and focuses on the key links of the approval of the import of drugs urgently needed in clinical practice. the current "series" evaluation and demonstration is adjusted to "parallel" development, and the national health commission guides the municipal health commission to form a joint expert group to carry out the evaluation and demonstration. at the same time, the evaluation and demonstration content of the varieties that are applied for import again is reasonably simplified.
the construction of the pilot zone for rare disease drug security is based on "security". on the basis of the green channel policy, it will give full play to the regional advantages of beijing tianzhu comprehensive bonded zone by establishing a "white list" system covering the entire process of temporary import, circulation and use of drugs urgently needed for clinical rare diseases. it will use the "bonded stocking" model to achieve "one-time customs clearance and multiple out-of-zone use" for rare disease drugs, and promote the transformation from "people waiting for drugs" to "drugs waiting for people".
in order to ensure the safety and traceability of clinical drugs and medical devices, the municipal drug administration has simultaneously issued guidance on the construction of a product traceability system for drug importers, improved the in-process and post-process supervision mechanism, and achieved closed-loop management of the entire process. currently, many medical institutions in beijing are actively preparing based on clinical needs.
the review period for supplementary applications has been shortened from 200 days to 60 days
in recent years, beijing has been deeply promoting the construction of the "two zones" in the field of biomedicine, taking the lead in striving for a number of national pilot policies, and the dividends of policy reforms have been continuously released. in the first half of this year, with the active efforts of the beijing municipal drug administration, two more drug review and approval reform measures were implemented in beijing.
one is the pilot program of "reducing the review period of supplementary applications from 200 days to 60 days". there are 161 chemical pharmaceutical manufacturers in beijing, with about 200 major change supplementary applications each year. previously, the national medical products administration was responsible for matters that required verification and inspection in the supplementary application process for drugs, and the completion period was 200 working days. in february 2024, the national medical products administration issued a work plan, intending to carry out pilot projects in beijing and other regions. the beijing municipal drug administration will provide pre-guidance, verification, inspection and other services to applicant companies in beijing, helping companies to directly enter the review and approval process after submitting major change application procedures to the national medical products administration. the time limit is shortened to 60 working days, which will further promote the iteration and upgrade of corporate technology and ensure clinical drug use. at present, the beijing municipal drug administration has formulated a pilot work management system, established a normalized communication and exchange mechanism with the national medical products administration's drug review center and other departments, and the first batch of review technical backbones have completed training.
another pilot is the pilot project of "reducing the approval period for drug clinical trials from 60 days to 30 days". in august 2024, the national medical products administration officially approved beijing to become one of the pilot areas for optimizing the review and approval of innovative drug clinical trials. the beijing municipal drug administration issued a notice to clarify the application path for pilot drug clinical trial institutions, and has now reviewed and released a list of 16 pilot institutions in two batches. enterprises applying to conduct class i innovative drug clinical trial projects are not subject to regional restrictions. they apply to conduct clinical trials in drug clinical trial institutions evaluated and approved by beijing. institutions that have been included in the pilot will serve as project leaders and submit applications to the drug review center of the national medical products administration. the review and approval will be completed within 30 working days after confirmation of acceptance. at present, the beijing municipal drug administration has recommended the first batch of projects to the national medical products administration.
to help "go global", beijing has exported more than 90 million doses of vaccines since the first half of this year
taking the opportunity of my country's joining the pharmaceutical inspection cooperation scheme (pic/s), and focusing on the bottleneck issues restricting drug exports, on july 1, 2024, the "beijing work plan to promote drug exports" was released to promote qualified enterprises to participate in the high-quality construction of the "belt and road" and other international cooperation.
cao wei introduced that since the first half of this year, beijing has exported 91.58 million doses of vaccines and 6.3 million doses of insulin and other biological products; the global sales of the innovative drug zebutinib incubated in beijing reached 8 billion us dollars, accounting for about 3/4 of the us market. the brain pacemakers, artificial lenses, and liquid helium-free superconducting magnetic resonance imaging manufactured by beijing's innovative enterprises pinchi medical, aibo medical, and wandong medical are exported to africa, europe and other places, and have been widely recognized by patients around the world, polishing the business cards of "made in china" and "made in beijing".
recently, three ministries and commissions issued relevant policies to allow foreign-invested enterprises to engage in the development and application of human stem cells, gene diagnosis and treatment technologies for product registration and production in china (beijing) pilot free trade zone and other places. cao wei believes that this shows that my country will further open up in the field of medicine and provide a broader platform for international cooperation and technological innovation.
cao wei said that in the next step, the beijing municipal drug administration will further strengthen the transformation and implementation of international common rules in china, promote the simultaneous development, application, review and marketing of global drugs in china, and allow the development results to serve the public health needs faster and better.
