印度CRO 學名藥BE 歐盟 質疑 (Micro Therapeutic Research Labs)

歐盟建議暫緩印度某藥廠測試藥品上市 2017-03-27 18:51經濟日報 記者易起宇╱即時報導 歐洲藥物管理局（EMA）在官網上表示，由於印度承包商微治療研究實驗室（Micro Therapeutic Research Labs）所進行的試驗「不可靠」，已建議各國暫停由該實驗室試驗的300多種學名藥的核准和申請。EMA的這項決定，是對印度藥品檢測產業的最新打擊，近年來國際監管機關發現印度藥品檢測產業問題叢生。EMA表示，自從奧地利和荷蘭官方去年2月提出疑慮後，歐盟官員一直在調查這家實驗室是否遵循正確的臨床實驗措施。EMA說，調查確認了外界對該公司的多項疑慮，包括研究數據的不當陳述和證明文件與數據處理方面的缺失。」不過，EMA並未掌握到這些藥品有害或缺乏效果的證據。

EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs/ European Medicines Agency 24/03/2017 The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The list of medicines recommended for suspension can be found here. The suspensions can be lifted once alternative data establishing bioequivalence are provided. Alternative supporting data have already been provided for several of the medicines reviewed. Therefore, the CHMP recommended that these medicines can remain on the market. The list of medicines recommended to remain on the market is available here. The Agency also recommended that medicines not yet authorised but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorised until bioequivalence is demonstrated using alternative data. Micro Therapeutic Research Labs is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU. The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company's sites regarding misrepresentation of study data and deficiencies in documentation and data handling. The review, by EMA's Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites. Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in certain EU Member States. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories. The CHMP's recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.