ABSTRACT
As an important complementary form of decoction pieces of traditional Chinese medicine（TCM）， TCM dispensing granules has the advantages of being free of decoction， easy to take， easy to carry and easy to be dispensed， which greatly improves the capacity of emergency services of TCM and is more in line with the needs of modern society. With the end of the pilot project of TCM dispensing granules， the market has been fully liberalized， the competition has been intensified， and it is in the transition period of switching between the new standard and the old one， and there are some problems such as the shortage of varieties， the change of specifications and the difference of quality， and the production enterprises are facing new opportunities and challenges. Based on this， the authors intend to systematically sort out the policies and regulations， enterprise layout and standard formulation since the pilot of TCM dispensing granules. In view of the problems in the post-pilot stage and from the perspective of survival and development of enterprises， it is suggested that enterprises should establish a quality control system for the whole industry chain of TCM dispensing granules to reduce process costs and increase enterprise competitiveness， further increase the investment in scientific research， overcome the key technical problems of difficult varieties， actively and orderly promote the research of national standards， in order to ensure the integrity of clinical formula varieties， and establish and improve the efficacy evaluation mechanism of TCM dispensing granules， build a consistency evaluation system between TCM dispensing granules and decoction pieces. Government departments should strengthen the guidance， fully mobilize the enthusiasm of scientific research institutions， enterprises and hospitals， and explore the establishment of "government-industry-study-research-application" mode to promote the development of TCM dispensing granule industry.
ABSTRACT
Objective To study the impacts of changes in medical device policies and regulations on the industry when the state department decides to revise Medical Devices Supervisory Management Act.Methods The impacts were discussed from the aspects of the scale of enterprise, number of product filing and registration and industry development environment. Results The changes of the policies and regulations had no great effect on the scale of enterprise while standardized the enterprise filing and registration and facilitated its development.Conclusion Management system based on medical device product lifecycle has been initially formed.Medical equipment enterprises should actively grasp the new regulatory changes and improve the quality compliance management by innovating product and technology, in order to make good use of the dividends brought about by changes in policies.
ABSTRACT
Objective:To explore the impact of recent changes in domestic policies and regulations on the development and appli-cation of generic drugs. Methods:Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion:According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge-neric pharmaceutical R & D institutions.
ABSTRACT
Health food containing Chinese materia medica (CMM) conforms to the development demands of the age of big health and the theory of preventive treatment. In the view of health care and improvement of resisting diseases, it plays an important role in the market. It is very necessary to have further study and discussion on health food containing CMM. First of all, by comparing, analyzing and summarizing, the health food containing CMM could be defined as the health food which is qualified in security and functionality evaluation, with the traditional Chinese medicines(TCM) within TCM standards as the main raw materials, and the formulation-composition is based on the theory of TCM. It is characterized by higher safety than medicines, stronger biological activities than common food, multiple forms, abundant raw materials and integrated supervision and management. Secondly, we discussed the research and development (R&D) strategies and rules of health food containing CMM, pointing out that the core tasks of R&D include the investigation of formula, technology and the standards of quality. The fundamental principles of declaration and production include scientificity, rationality, reality and uniformity. Three key requirements (security, functionality and controllability) in the review as well as the process management of R&D and the key-points of risks control were summarized in this paper. Finally, the dynamic trends of policies and regulations related to health food containing CMM were analyzed in the view of registration, recording, raw materials and functions, and then related suggestions were proposed. Therefore, this article will be helpful in overall understanding the health food containing CMM and play a guiding role for its research and development.
ABSTRACT
The fast transmission and large range of emergence of infectious diseases jeopardize human health, social and economic development, which is a great threat to global public health. World Health Organization for the new features of infectious diseases on theInternational Health Regulations was revised to help member countries improve the ability to respond to public emergencies. Our government promptly revised theCommunicable Disease Prevention Act, enacted a series of laws and strategies to promote the establishment of infectious disease surveillance and response systems. Chinese medicine was included in the country infectious disease prevention and control system. After nearly 10 years of development, the prevention and treatment of Chinese medicine on emergence of infectious diseases, the clinical medicine and research capacity of respond infectious diseases has been significantly improved, and become an important part of our system of infectious disease prevention and control.