鄒玫君組長中文.pptVIP

BA/BE試驗查核 2002年起執行查核 執行試驗，應依循GCP 檢體分析，應依循GLP 另有依BA/BE試驗特性之依循事項 依審查需要執行查核 已查核國內執行之BA/BE試驗 包括臨床試驗及分析試驗處所 原料藥法規要求 新藥與生物製劑的原料藥DMF 2002公告實施原料藥GMP制度及鼓勵措施 2009公告原料藥主檔案(DMF)技術資料審查表及申請注意事項(配合全民健康保險第6次年度藥品支付價格調整作業原則) 專利權議題 Disclosure of patent Declaration of patent non-infringement The review of generic drug and the information of patents are normally linked Review of patent infringement cases- Intellectual Property Court Patent-related litigation and the quality of review had been enhanced and accelerated since the Intellectual Property Court was established on July 1st, 2008. * 資料專屬權議題 Pharmaceutical Affairs Act Article 40-2 The second paragraph hereof con only be applicable with the compliance that application for registration of a new drug of new molecular entity shall be made to the Central Competent Health Authority within three years after it is first approved for marketing in any country. * Generic drug labeling Review Regulations for Registration and Market Approval of Pharmaceuticals Article 20 Generic drug labeling of the surveillance drugs*, should follow the first approved labeling; labeling of the non-surveillance drugs** should be translated according to the innovator’s labeling. But drug labeling has not been excluded from the copyright act, which might cause the lawsuit. *surveillance drugs: chemical entity first approved after 1983. **non-surveillance drugs : chemical entity first approved before 1983. 著作權議題 * Drug labeling – fair use for public benefit Copyright Act Article 65 Fair use of a work shall not constitute infringement on economic rights in the work. In determining whether the exploitation of a work complies with the provisions of Articles 44 through 63, or other conditions of fair use, all circumstances shall be taken into account, and in particular the following facts shall be noted as the basis for determination. The court decision for lawsuit cases : Drug labeling should refer to Copyright Act Article 52 “Within a reasona