SCIO briefing on strengthening drug regulation to ensure drug safety for the public
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E-mail China.org.cn, July 28, 2023
CCTV:
Since the reform of the evaluation and approval systems for medicine and medical equipment, the pharmaceutical industry has seen significant innovation progress. Can you discuss the research and development of innovative medicine and medical equipment, as well as their market entries in recent years? Going forward, what policies will be implemented to support innovation, and in which areas will you focus on encouraging innovation and development?
Jiao Hong:
Thank you for your questions. I will answer them. In recent years, the NMPA has deepened the reform of evaluation and approval systems for medicine and medical equipment. It has also rolled out supportive policies to encourage innovation. As you said, judging from the number of drug and medical equipment applications received and approved, including those in the first half of the year, we can see China's robust achievements in innovative medicine and medical equipment. Encouraging innovation is the core of reforming evaluation and approval systems for medicine and medical equipment. In recent years, we have revised and made supporting regulations, including registration management regulations for medicine and medical equipment, and continuously harnessed the policy's benefits. More than 100 medicine products are approved each year through prioritized evaluation procedures. In recent years, by optimizing resources, priority in terms of evaluation has been given to new medicine products that are in urgent clinical need and have proven clinical value. These products include pediatric medications and orphan drugs. Take pediatric medication, which is of significant public concern, for example. In recent years, we have stepped up efforts to revise and make regulations on pediatric medication. A total of 66 pediatric medications were approved to enter the market last year, and 46 pediatric medications were evaluated in the first six months of this year. We have channeled resources to new medicines of proven clinical value as well as medicines and medical equipment in urgent clinical need to promote their market entry. These measures have further encouraged innovation and boosted the high-quality development of biomedicine.
The report to the 20th CPC National Congress systematically expounded on accelerating the establishment of a new development paradigm and redoubling efforts for high-quality development. As we all know, the medical industry is a vigorous industry with a promising future. In recent years, the NMPA has enhanced efforts in China's drug regulatory science action plan, through which drug regulatory work would be more science-based and forward-looking. I will briefly introduce the measures we have taken to encourage innovation. Going forward, we will further consolidate and enhance the development achievements of reforming the evaluation and approval systems.
First, we will further intensify our work on enterprise R&D and innovation. For example, we will improve evaluation and approval procedures for conditional market applications and ensure science-based, strict, procedure-based, and efficient drug evaluation work. Meanwhile, we will further optimize the approval of drugs in urgent clinical need, medical equipment, pediatric medication, orphan drugs, the domestic counterparts of imported drugs, as well as products of core and key technologies. We will prioritize evaluation work and improve the mechanism by integrating research and evaluation. We will step up efforts to make technical guidelines and enhance guidance and services for enterprises' product R&D.
Second, we have constantly advanced the consistency of generic drug evaluation work to ensure quality and efficacy on par with the original drugs. We will continue releasing reference product catalogs and improving relevant technical guidelines. Based on trial work on oral solid preparations and injections, consistency evaluation of other types of generic drugs will be steadily advanced.
Third, we will encourage R&D, as well as the application of radiopharmaceuticals, and reform and improve the evaluation and approval process for these substances. We will make full use of radiopharmaceuticals' role in diagnosing and treating malignant tumors, and cardiovascular and cerebrovascular diseases, in a bid to improve China's capabilities in the research, development, and application of radiopharmaceuticals.
The last point concerns the management of drug package inserts, which is of interest to many. We will advance pilot programs to introduce senior-friendly package inserts so seniors can see them. We will choose some orally-taken drugs and externally-used drugs commonly used by seniors and require drug developers to provide simplified package inserts with larger font sizes. Enterprises will also be encouraged to provide speech synthesis and braille services. Thank you.
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