2019年前，FDA将建立GMP等相关检查合规状态数据库

beiwei5du

2019年1月前，美国FDA将对所有的 GDUFA self-ID facilities and sites建立相关的合规状态数据库（药厂的GMP检查，涉及到BA/BE研究的机构）。这个应该相当于EU的EudraGMDP数据库，FDA所建立的数据库可能不仅仅涉及到GMP，可能会像加拿大的合规数据一样（https://www.ouryao.com/forum.php?mod=viewthread&tid=274369&highlight=gmp%2B%CA%FD%BE%DD%BF%E2），如下图database.其同时可能会显示compliance，non-compliance,inspection in progress,inspection scheduled等状态信息以及历史检查状态。中国什么时候能建立此种数据库，以便于GMP等相关检查的透明性呢？？？

F.  GDUFA II Facility Compliance Status Database
By January 1, 2019, FDA will update its existing, publicly available database that describes the compliance status of GDUFA self-ID facilities and sites.  Compliance status is based on the most recent inspection or related FDA action for facilities involved in any manufacturing activities subject to CGMP inspection and for sites involved in the conduct or analysis of bioanalytical or clinical bioequivalence/bioavailability studies conducted to support an
ANDA. The database will be updated every 30 days and will reflect FDA’s final assessment of the facility or site following an FDA inspection and review of the inspected entity’s timely response to any documented observations.  The public website containing the database will also include an explanation of terms used to describe the compliance status of facilities and sites.  
选自《GDUFA II Commitment Letter》
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf


Facility Assessment Enhancements.
As previously mentioned, FDASIA eliminated longstanding minimum inspection frequency requirements and, instead, directed FDA to inspect drug facilities globally on the basis of risk. The transition to this new paradigm has been commercially disruptive for industry, which over time had developed expectations and business processes based on the old model. To mitigate export-related challenges identified by U.S.-based active pharmaceutical ingredient (API) manufacturers, GDUFA II would require FDA to issue guidance and conduct outreach to foreign regulators on the risk-based selection model and take steps to support exports. To mitigate ANDA sponsor concerns, FDA would enhance the speed and transparency of communications concerning facility assessment, and generally update and seek feedback from industry. In addition, to enhance transparency concerning GDUFA facilities and sites, FDA would update its existing, publicly-available facility compliance status database.
选自《Generic Drug User Fee Act Reauthorization (GDUFA II), Biosimilar User Fee Act Reauthorization (BsUFA II)》
https://www.fda.gov/NewsEvents/Testimony/ucm548273.htm

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