Previously, the national agency for medicines and medicines issued the special regulations for the control of chinese drug registers (known as the special provisions), which became effective on 1 july 2023. The special provisions contain 11 chapters, 82 of which include general provisions, classification and listing of chinese medicines, rational application of empirical evidence, chinese drug innovation, improved chinese medicine, ancient classic chinese drug combinations, generic drugs, post-market changes, standards for registration of chinese medicines, drug names and instructions。
In the view of industry, the special provisions are in harmony with the new revision of the medicines management act, the medicines register management scheme, which emphasizes human experience and clinical value, facilitates innovative research and development of chinese medicine, and favours chinese medicine, self-care and innovative chinese medicine enterprises。
Build a chinese drug registry management system
In recent years, the state council, the department of health and social security and the national drug administration have produced several heavy-pound documents to promote innovative development in chinese medicine transmission, which has entered a new era. The purpose of this special provision is to promote the innovative development of chinese medicine transmission and to strengthen the development and registration of new chinese medicine in accordance with chinese medicine research。
According to the special provisions, the registration classification of chinese drugs includes chinese drug innovation, chinese drug improvement, ancient classic combinations of chinese medicine, and generic drugs. The development of new chinese medicines should be combined with the registration classification of chinese drugs and the selection of research and development paths or models that are appropriate to their characteristics, depending on the variety. Tetrapharmaceutical drugs based on chinese medicine theory and human experience to detect and explore therapeutic effects, are confirmed mainly through human experience and/or necessary clinical trials; pharmacological screening studies determine the chinese medicine to be developed, and the necessary i-phase clinical trials should be carried out in sequence and in phases ii and iii。
The special provisions provide for priority consideration of applications for registration of new medicines, etc., in cases where the clinical location is clear and of clear clinical value: for use in major diseases, new outbreaks of infectious diseases, rare diseases; for urgent clinical needs and market shortages; for use by children; for newly discovered medicines and their preparations, or for new uses of drugs and their formulations; for a clear and well-functioning substance base。
Policy supports the development of new chinese medicine for clinical practice in chinese medicine. According to the special provisions, new chinese medicines derived from clinical practice, where experience can provide research and support evidence in clinical positioning, applicable mass screening, treatment exploration, dosage exploration, etc., are not subject to the second phase of clinical trials; antiquated prescriptions for combinations of drugs in ancient classics, which do not contain antiquated taboos or drug standards that are highly toxic, highly toxic, and are proven toxic by modern toxicology, should be prepared using traditional techniques, using traditional delivery routes and functionally in chinese medical terminology. The development of combination formulations for this category does not require non-clinical effectiveness studies and clinical trials。
According to the national drug control agency, the specialized provisions further refine the requirements for the development of chinese medicines and strengthen the development and registration of new chinese medicines on the basis of the universal requirements for drug registration management. The special provisions take full advantage of the experience of the reform of the drug review and approval system and explore it in the light of the results of the transformation of chinese medicines in the prevention and control of the epidemic, drawing on the results of the national and international drug control research, and developing a comprehensive and systematic system for the registration and management of chinese medicines, and making every effort to modernize chinese drug control。
Dong wu considered the special provisions to be a further revision and refinement of the china drug registration classification and reporting information requirements issued by the national drug authority in 2020. The special provisions further implement, through the necessary technical requirements, the accelerated development of an evidence system for the evaluation of chinese medicines that combines chinese medicine theory, human experience and clinical trials, reflects new concepts and reform initiatives for the management of chinese medicines registration, and strengthens guidance for the development of chinese medicines with greater integrity。
Turning firms into innovation
After the introduction of the special provisions, dong wu stated that the classification and listing of chinese medicines, the rational application of empirical evidence, chinese drug innovation, chinese drug improvement, ancient classic chinese drug combinations, etc., required greater specificity and clarity, and that the chinese drug industry had a clearer direction and direction in terms of pipelines, and was expected to further promote the declaration and approval of chinese drug innovation companies。
In addition, the special provisions provide for further industry requirements, reflecting the continued strengthening of industry regulation. According to the special provisions, holders should strengthen the management of drugs throughout their life cycle and the monitoring, evaluation and analysis of safety risks, and should refine the chinese drug instructions [prohibited], [negative reactions], [notices] in a timely manner, taking into account relevant technical guidelines. Any one of the chinese drug instructions [prohibited], [negative reaction] or [notice] is still “undefined” when applying for re-registration of a drug after three years from the date of application of this provision, and is not re-registered in accordance with the law。
According to the league of nations securities, the above-mentioned provisions force enterprises to transform to innovation. Small and medium-sized producers will seek m&as from leading firms; they will be expected to gain more market shares by taking advantage of policy dividends based on safety information on statements that have refined major varieties based on pre-research and development potentials of chinese drug innovation; some companies will be proactive in conducting evidence-based medical research on major non-exclusive varieties, leading to evidence-based clinical or real-world research on the basis of financial advantages, and market shares for non-exclusive varieties will be concentrated in lead firms; and chinese pharmaceutical companies will continue to conduct evidence-based medical research over the next three years, with the expectation that the clinical cro industry will develop。
Since the reform of the chinese drug registration system at the end of 2020, there has been a marked increase in the number of new chinese drug declarations, from 1371 in 2021 to 1,551 in 2022. The evaluation also increased significantly and between 2021 and december 2022, 19 new chinese drugs, including silver-cracked hot tablets, were cumulatively approved. The number of new chinese drugs approved has increased significantly over the past five years, further facilitating the process of developing chinese medicines。
According to the league of nations securities, national top-level strategies continue to benefit the innovative development of chinese medicine. It is believed that a comprehensive and systematic chinese drug registration and management system will have a positive impact on the ongoing upgrading of regulation in the chinese and chinese pharmaceutical industry, which is expected to contribute to the long-term high-quality development of the industry。
Watch the four main lines
According to chase securities, support for payment-end policies accelerates the availability of medicines in the chinese pharmaceutical industry, and part of the drug supply during the epidemic has played an important role in accelerating demand-side growth, adding a number of enterprises to state enterprise reforms, equity incentives, continued improvements in the performance of some companies and visible restoration of the valuation of the plate。
According to shinjian, the care of chinese medicine, self-care and innovative chinese medicine enterprises are mainly concerned with four main lines. With regard to optimizing the main routes of the epidemic, based on experience abroad, the demand for self-diagnostic drugs has continued to rise as the policy of prevention has been refined, and the demand for respiratory drugs has increased significantly。
In the area of chinese consumer goods, the brand otc has evolved over time as industrial policies and patterns change, and it is hoped that it will gradually move into a high-quality development phase. In the broader context of a further increase in the concentration of chinese consumer brands, chinese drug companies will gradually move into a high-quality development phase, as brands expand, channels expand, and brands with strong pricing capabilities。
In the area of chinese medicine innovation and prescription drugs, as our system for the review and approval of chinese medicines continues to improve and improves, it is expected that the chinese medicine innovation will gradually be on track for high-quality development and that, at the same time, as the dividends of chinese medicine policy continue to be released, the chinese medicine prescription will be available for a period of time。
With regard to chinese formulation particles, the pilot phase of the chinese formulation was completed in november 2021, with the promulgation of national standards, the formal implementation of the new national marker, the gradual pace of national switching, and the expected increase in the recovery of chinese formulation particles in 2023。
