The past decades had witnessed the efforts made by China’s pharmaceutical registration and approval system, on ensuring drug safety and protecting public health. Current pharmaceutical registration and approval system was established in 2007, some problems and loopholes are gradually exposed during the implementation. Current system is hard to catch up with, even hinder, the development of China’s pharmaceutical industry. As the representative of pharmerging country, China’s pharmaceutical registration and approval system not only has great impacts on domestic pharmaceutical industry, but has huge influences on global pharmaceutical R&D, manufacturing and distribution. Therefore, it is of great significance to study the current pharmaceutical registration and approval system in China. This study introduces the current system in the beginning, then analyzes current status and problems in regulation with the aid of data, documents and publication, the problems can be generalized into four aspects: low drug review efficiency, outdated registration and approval process, excessive low-level repeated application and defective intellectual property protection system. Pursuant to the problems, this study provides several policy suggestions: firstly, in order to improve review efficiency, CFDA may consider decentralizing some power to provincial counterparts, outsourcing technical review and modifying drug registration charging system; secondly, in the aspect of improving registration process, this study advocates the enforcement of filing system in bioequivalence study and the full recognition of ICH Common Technical Document (CTD) and international multi-center clinical trial; thirdly, to reduce the low-level repeated ANDA, CFDA may consider establishing ANDA pre-screen procedures and publishing the registration information to the public regularly; fourthly, to encourage pharmaceutical R&D, it is necessary to establish MAH system fitted for China’s condition and drug patent term restoration system.

中國藥品註冊審批制度在過去的幾十年裡承擔起了保證藥品安全，保衛公 眾健康的重要職責。現行的藥品註冊審批制度建立於 2007 年，在將近八年的發 展過程中，暴露出了一系列的問題與漏洞，愈加難以滿足中國制藥產業快速發 展的客觀需求，甚至一定程度上阻礙了中國製藥產業的發展。作為藥品新興大 國，中國的註冊審批制度不僅影響著本國製藥生產企業的發展，而且在經濟全 球化背景下，也會對全球藥品研發、生產、流通格局產生巨大的影響，因此探 究與分析中國現行藥品註冊及審批制度具有重要意義。 本研究從介紹中國藥品註冊審批制度體系出發，用相關數據和文本資料分 析當前註冊審批體系的現狀及問題，主要包括藥監機構審評效率過低、部分註 冊審批機制不合理、仿製藥低水準重複申報問題突出以及藥品知識產權保護體 系不完善。根據註冊制度存在的問題與爭議，本研究提出了四點政策建議：第 一，在提升審評效率方面，可以藉助權力下放、購買外部審評資源、調整藥品 註冊收費策略來實現；第二，在優化註冊程序方面，本研究提倡實行生物等效 性試驗的備案制，同時提倡實現對 ICH 通用技術文件和國際多中心試驗的全面 認可；第三，在減少低水準重複申報方面，應當逐步建立仿製藥申請篩選性審 查制度，逐步建立藥監註冊信息發佈機制；第四，在鼓勵新藥創製方面，應探 索符合中國國情的上市許可人制度，建立藥品專利期補償機制。