Industry Analyze And Strategy On Management Standard Researching Of Drugs License Renew Application In Sichuan Province

Objective:Aim at the situation and the speciality of license renew application in Sichuan Province, to comprehend the importance of license renew, and to improve the level of license renew application, to promote the institutionalization, normalize, scientization of supervising license renew application, which promote the sustainable development of medical economy.Method:In accordance with license renew relevant regulations domestic and overseas, reviewed related articles, investigate the system of license renew application in Sichuan Province, which included the number of Approval Number, variety distribution and production status. To participant some practical activities which are about license renew application of the Drug regulatory department in Sichuan Province, analyze the situation and problem of license renew in Sichuan Province. Discussed the reason of restrict license renew and drug development of Sichuan Province and aim at the tendency of medical industry development and the actual situation of license renew administration in Sichuan Province, propose the construct mentality of license renew administration system and the strategy of medical industry development.Result:in various aspects investigation, there are opportunities and challenges of license renew application in Sichuan Province. The abundant resource is our advantage and also achieved lots of approval documents, completed dosage form, lots of exclusive productions. But the pharmaceutical factories’products are insufficient, repetition dosage form, drug construction unreasonable, lack the registry department in factory, lack of professionals, staff instability who is responsible for registry, applicate out date by these enterprises which effect the process of license renew administrate normalized in Sichuan Province.Conclusion:To normalize Sichuan license renew administration as soon as possible, should break through these restricts, definite the report of "sails and clinical use situation", and normalize the activities of enterprise’s manufacture, enhance the awareness of quality, innovate Sichuan license renew administration methods, explore new management mode, strengthen supervision by government, exert the guiding role in drug registry quality control by government. Strengthen the administration of ADR report process by enterprise, enhance the awareness of the responsibility administrate by the enterprise themselves. New drug phase Ⅳ clinical trial administrate mechanism, implement the goal of post-marketing quality supervision. Develop license renew application information platform, reform and complete the process of examination and evaluation, improve quality and levels. Reform and complete the process of examination and evaluation which is to review in different time, variety, batches. To develop license renew application information platform and enhance the examination and evaluation work’s credibility. Speed up the setting up of enterprise’s drug registry department, enhance the training of professionals. Develop the safety of license renew accountability system.