Financial Associated Press, March 4th (Reporter Jia Xiaoning)A reporter from the Financial Associated Press learned that Xiao Wei, a representative of the National People’s Congress, academician of the Chinese Academy of Engineering, and chairman of Kangyuan Pharmaceuticals, put forward two suggestions for promoting the development of the Chinese medicine industry during the two sessions of the country this year.
In recent years, the country has vigorously developed the cause of traditional Chinese medicine, and the report of the 20th National Congress of the Communist Party of China emphasized “promoting the inheritance, innovation and development of traditional Chinese medicine”. Faced with this historic development opportunity, Xiao Wei, as a well-known domestic expert in traditional Chinese medicine, suggested that the “Special Regulations on the Registration and Management of Traditional Chinese Medicine” be fully implemented as soon as possible, and the promotion of intelligent supervision of drug production should be accelerated.
Promoting the implementation of the “Special Regulations” as soon as possible
On February 10, 2023, the State Food and Drug Administration issued the “Special Provisions on the Administration of Registration of Traditional Chinese Medicines” (hereinafter referred to as the “Special Provisions”), which will be implemented on July 1.
According to a reporter from the Financial Associated Press, the “Special Regulations” continues the essence of the “Supplementary Regulations on the Administration of Registration of Traditional Chinese Medicine” issued in 2008, absorbing 15 years of experience in drug review and approval in my country and the transformation of relevant Chinese medicine achievements in the three-year epidemic prevention and control process. Specific practice exploration, and organic connection with the newly promulgated “Chinese Medicine Law”, “Drug Administration Law”, and “Measures for the Administration of Drug Registration”, are an important part of the comprehensive and systematic construction of a traditional Chinese medicine registration management system.
For the implementation of the “Special Regulations”, Xiao Wei suggested that we should first increase policy publicity and interpretation, innovate training methods, and be organized and coordinated by the provincial food and drug regulatory departments. Systematically and pertinently solve the difficult problems encountered in the research and development of traditional Chinese medicine, fully organize and promote the implementation of the registration management policy of traditional Chinese medicine to be effective, help pharmaceutical companies understand the policy and be able to implement it, and effectively strengthen the drug marketing licensees and enterprises to further increase the research and development of traditional Chinese medicine Confidence in launching new drugs.
Second, promote new ideas and methods, strengthen the concept of “clinical value-oriented, emphasizing human experience, and whole-process quality control” in the development of traditional Chinese medicine, patient-centered drug development, adaptive design and enrichment design, and quality by design The popularization and implementation of new concepts, new methods and new tools in the process of R&D and production of traditional Chinese medicines, drug life cycle supervision, etc. Clinical research and other aspects are monitored and managed throughout the process.
Third, promote the supervision and construction of research and development data such as human experience, and improve the effectiveness of preparation supervision in medical institutions. It is suggested that on the basis of fully understanding the characteristics and laws of traditional Chinese medicine, absorbing international experience, strengthening the supervision of preparation data in medical institutions with the core of experience in human use of traditional Chinese medicine, from the aspects of topic selection, clinical scientific research integrated information platform, clinical practice, adverse reaction monitoring, etc. Carry out scientific research on human experience data, promote the construction of a medical institution preparation smart supervision model centered on human experience data, and the State Administration of Traditional Chinese Medicine will lead and organize multiple forces to select and form a group of typical model medical institutions and demonstration enterprises with smart supervision , promote the collection and collation of high-quality human experience data, and promote the transformation of medical institution preparations into new traditional Chinese medicines.
Xiao Wei believes that the new era of registration management of traditional Chinese medicine has arrived, and the implementation of the “Special Regulations” is to further stimulate the new vitality of the innovation and development of traditional Chinese medicine and make new contributions to better meet the health needs of the people. To fully implement it, multiple departments are needed Coordinated progress to promote the implementation of the “Special Provisions” as soon as possible.
Promoting intelligent supervision of drug production
As the person in charge of a large Chinese medicine company, Xiao Wei proposed to accelerate the promotion of intelligent supervision of pharmaceutical production in order to better promote the digital and intelligent transformation and upgrading of the pharmaceutical industry, achieve high-quality industrial development, and help transform from a large pharmaceutical country to a pharmaceutical power.
Its main contents include: accelerating the information transformation of “integrated management and control” of pharmaceutical production enterprises, laying the foundation for the realization of intelligent supervision of pharmaceutical production; establishing a unified national drug production intelligent supervision platform and intelligent supervision standard system, and promoting drug supervision to intelligent High-quality transformation of standardized supervision; establish a safe and shared intelligent supervision mechanism for drug production, and protect the intellectual property rights of production enterprises and the public’s right to know.
In his proposal, Xiao Wei pointed out that the purpose of accelerating the supervision of smart production of traditional Chinese medicine is to produce high-standard and high-quality traditional Chinese medicine on the basis of traditional Chinese medicine prescriptions, which will be recognized by the industry and patients.
Regulatory data is inseparable from a stable production process and basic information means. If multiple information management systems such as ERP, MES, and DCS in the drug production process are organically combined, it can help drug manufacturers realize “integration of management and control” , forming the collection and acquisition of production process data. It is recommended to select some representative pharmaceutical companies with good informatization foundation as demonstrations, and focus on a batch of varieties or high-risk varieties with large output and high clinical coverage, and try them first.
Establish a nationally unified “high-quality standard” for intelligent production supervision, collect the supervision data platforms established by the provincial and municipal supervisory departments and affiliated enterprises on the national unified data platform, and use the “Chinese Pharmacopoeia” drug quality technical standards as the basis, Collect key process parameters and quality attributes that can reflect the real quality level, and study and establish unified regulatory standards. On this basis, combined with the progress of the enterprise’s intelligent transformation, gradually realize the supervision of process and quality consistency, form a “high-quality standard” for production intelligent supervision, and comprehensively improve the quality of drugs.
At the same time, in order to ensure the safety of drugs, establish a safe and shared smart drug production supervision mechanism to protect the intellectual property rights of manufacturing companies and the public’s right to know. Xiao Wei suggested that the regulatory authorities should set up a “reliable turnkey” project platform to ensure the core data of the enterprise while smoothing the channels for the public to query drug data and encourage the public to actively participate in drug supervision.
(Editor: Cao Jingchen)