Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions" / 中国中药杂志
China Journal of Chinese Materia Medica
; (24): 1120-1125, 2022.
Article
em Zh
| WPRIM
| ID: wpr-928032
Biblioteca responsável:
WPRO
ABSTRACT
Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.
Palavras-chave
Texto completo:
1
Base de dados:
WPRIM
Medicinas Tradicionais:
Medicinas_tradicionales_de_asia
/
Medicina_china
Métodos Terapêuticos e Terapias MTCI:
Terapias_biologicas
Assunto principal:
Medicamentos de Ervas Chinesas
/
China
/
Saúde Pública
/
Prescrições
/
Medicina Tradicional Chinesa
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2022
Tipo de documento:
Article