5/18付でEMAから審査関係の更新通知が発出されています。
これら通知類は「Regulatory and procedural guideline」などと合せて時折更新されます。
これら通知類は「Regulatory and procedural guideline」などと合せて時折更新されます。
関係者にあっては、「What's New?」ウェブサイト（下記URL）
● 個々の通知類（審査関係のため安全性に関わるものも加えています）
Type-IA variations: questions and answers (updated)
Type-IB variations: questions and answers (updated)
Extensions of marketing authorisations: questions and answers (updated)
Type-II variations: questions and answers (updated)
Grouping of variations: questions and answers (updated)
Renewal and annual re-assessment of marketing authorisation (updated)
Post-authorisation measures: questions and answers (updated)
Post-authorisation safety studies (PASS) (updated)
Periodic safety update reports (PSURs) (updated)
Risk management plan (RMP): questions and answers (updated)
Transfer of marketing authorisation: questions and answers (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
Pre-authorisation guidance (updated)
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経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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