※追記更新（2020.08.18）
8/10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。
8/10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。
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）
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human (updated)
Validation issues frequently seen with initial marketing authorisation holders (updated)
Classification of changes: questions and answers (updated)
Type-II variations: questions and answers (updated)
Transfer of marketing authorisation: questions and answers (updated)
Post-authorisation safety studies (PASS) (updated)
Grouping of variations: questions and answers (updated)
【8/18付追記更新】
Pre-authorisation guidance (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human (updated)
Validation issues frequently seen with initial marketing authorisation holders (updated)
Classification of changes: questions and answers (updated)
Type-II variations: questions and answers (updated)
Transfer of marketing authorisation: questions and answers (updated)
Post-authorisation safety studies (PASS) (updated)
Grouping of variations: questions and answers (updated)
【8/18付追記更新】
Pre-authorisation guidance (updated)
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