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Pharmaceutical Network Industry Dynamics: Chinese medicine formula particles from single-taste Chinese medicine drink tablets by water, concentrated, dry, granulated, eliminating the traditional Chinese medicine cooking process, and easy to carry Due to the advantages of Chinese medicine formula particles themselves, more and more patients will choose to buy formula particles In terms of policy, China has promoted the development of Chinese medicine in recent years, in order to reduce the burden of patients in the future, it is expected that the formula particle probability can enter the national health insurance directory This is a strong capital, the direction of development is a big advantage for large enterprises, more and more Chinese medicine enterprises began to lay out the formulation of particles field
It is understood that in order to promote the scientific and technological innovation and industrial development of The Biopharmaceutical Industry in Shanghai, promote the transformation and upgrading of the Chinese medicine industry, and meet the clinical needs of Chinese medicine, the Shanghai Science and Technology Commission (hereinafter referred to as the Municipal Science and Technology Commission), the Shanghai Municipal Drug Administration (hereinafter referred to as the Municipal Drug Administration) and the Shanghai Municipal Administration of Traditional Chinese Medicine (hereinafter referred to as the Municipal Chinese Medicine Bureau) jointly launched the declaration of the research project of Chinese medicine formula particles The project is declared from April 8, 2020 to May 6, 2020 at 15:00 p.m
The project will complete the production process of Chinese medicine formula particles and the construction of quality control system throughout the industry chain, the total number of varieties is not less than 300 The research includes carrying out the production process of Chinese medicine formula particles, the whole industry chain quality control system and clinical trial, which provides support for improving the safety, effectiveness and quality control of Chinese medicine formula particles Through research, the state published uniform standards of varieties, the establishment of a corresponding quality control system, the country has not yet published uniform standards of varieties, in accordance with the State Drug Administration issued the "Technical Requirements for the quality control of Chinese medicine formula particles and standards to develop technical requirements" to carry out research, the establishment of a quality control system
The conditions for declaration are as follows: 1, the declaration unit should be the city to obtain the "drug production license" of chinese medicine production enterprises, and with Chinese medicine tablets, granules, Chinese medicine extraction workshop production scope and independent Chinese medicine formula grain production site and personnel and other conditions
2, the declaration unit must have the Chinese medicine tablet scouring, extraction, concentration, drying, granulation and other complete production capacity, can fix the origin of Chinese herbal medicine, establish or cooperate in the establishment of Chinese herbal medicine planting base, the number of base procurement varieties not less than 50% of the pilot varieties, with the Chinese herbal medicine traceability management system and perfect drug quality assurance system and quality management capacity, in line with the "drug production quality management norms" (GMP) requirements
3, the declaration unit has completed the production process and quality standards of the total number of Chinese medicine formula granules shall not be less than 300
4, research and production of Chinese medicine drink tablets must comply with the "Chinese Pharmacopoeia" or "Shanghai Chinese medicine tablets concocted specifications" quality requirements
5, the project responsible person must have a senior professional and technical position, the age is generally not more than 55 years old (born after April 1, 1965), with strong organizational coordination ability and a better basis for scientific research
6, the declaration enterprises should have the corresponding research and development conditions and financial input capacity, for the project research and industrialization of financial protection.