FDA CDER Announces Issuance of Part 11 Q&A Guidance in FY2022
In January, the Center for Drug Evalutation and Research (CDER), which has jurisdiction over FDA’s human drugs, released its FY2022 list of guidance to be issued.
この中に「Use of electronic records and electronic signatures in clinical trials under 21 CFR Part 11 – Questions and Answers」が掲載された。
This guidance was issued in draft form in June 2017. It is expected to be finalized and issued this year.
This guidance is a Q&A on the application of Part 11 in clinical trials. The format of the document is a statement of FDA’s thinking.
Q2. For electronic systems owned or managed by sponsors and other regulated entities that fall under the scope of 21 CFR part 11, what will be FDA’s focus during inspections?（21 CFR Part 11の範囲に該当するスポンサーおよびその他の規制対象組織が所有または管理する電子システムの場合、査察時のFDAの焦点は何か？）
Q10. If a non-U.S. site is conducting a clinical investigation, are records required by FDA regulations Q10. If a non-U.S. site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements?（米国以外のサイトが臨床試験を実施している場合、FDAの規制で要求される記録はPart 11の要件の対象になるか？）
and other topics of interest to Japanese pharmaceutical companies.
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