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Research On The Current Situation And Countermeasures Of Pharmaceutical Ingredients Management In China

Posted on:2015-03-07Degree:MasterType:Thesis
Country:ChinaCandidate:Z LiuFull Text:PDF
GTID:2134330467480675Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
Objective:according to the particularity of pharmaceutical excipients effects, standard accessories market order,improve the material quality, the development of new materials,to ensure safety of medicinal materials.Methods:the investigation was carried out on the current situation of the development and application of domestic pharmaceutical excipients, pharmaceutical development needs and future development trend of domestic and foreign markets. From the national "shierwu" planning, promotion and development of medicinal materials industry is big trend; the improvement and innovation of the new version of the GMP implementation specification, excipients regulatory mechanism and new medicinal materials development and quality and other aspects of in-depth analysis and research, the literature summary, and probe into. Results:in the systematic combing of the medicinal material management situation of our country, based on the profound analysis, summary, at present, our materials production, management enterprise quantity is many, the scale small; professional relatively low level of division of labor, management of technology and innovation is insufficient, the creation of brand awareness is not strong, resulting in medicinal materials of our products concentration is not high; accessories packaging rough, unconvincing on product quality, product structure is single; the number of new pharmaceutical products, low technology content, products of independent innovation, enterprise self sealing characteristics, competitiveness is not strong. Especially in the international materials market share is very few, Chinese medicinal materials development and regulatory lag effect, the new development of pharmaceutical industry.Conclusion:according to the research results, discussed China’s pharmaceutical excipients regulatory system and development platform. The establishment and improvement of the medicinal materials information sharing platform, strengthen medicinal materials quality management awareness, standardize enterprise behavior of pharmaceutical excipients, government departments to strengthen supervision according to law. To strengthen and improve enterprise internal quality standards, adapt to the requirements of the product quality law. Establish and improve the processing excipient special standard, innovation, quality of medicinal materials varieties, improve the quality of preparation, to promote the development of new dosage forms. Optimization of industry resources, construction of drug and excipients research, production, management of industry alliance, to improve the level of intensive development. Accessories industry only take the initiative to adapt to market demand, exert industrial advantage, scientific research advantage, market advantage, composed of industry alliance, and realize the sharing of resources, to risk sharing, quality assurance, win-win development goals.
Keywords/Search Tags:pharmaceutical, supervision, and management, mechanism
PDF Full Text Request
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