※2016.06.07 情報更新
※2016.06.10 情報更新
4/19付のGMP Platform「EMA／審査関係の更新通知（2016年4月付） 」の続編とも言える更新通知が6/2付でEMAから多数発出されています。
これら通知類は「Regulatory and procedural guideline」などとして定期的に更新されます。
今般更新された通知類には下記のものがあります。
関係者にあっては、「What's New?」ウェブサイト（下記URL）かあるいは個々のタイトルからリンク先あたってください。
● 「What's New?」ウェブサイト
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4
● 個々の更新通知類
Type-IB variations: questions and answers (updated)
Type-IA variations: questions and answers (updated)
Type-II variations: questions and answers (updated)
Extension applications: questions and answers (updated)
Generic / hybrid applications: questions 35 to 43 (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
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: document with track changes (updated)
Post-authorisation measures: questions and answers (updated)
Other post-authorisation activities: questions and answers (updated)
Human post-authorisation Q&A: Introduction (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
Pre-submission queries service: questions and answers (updated)
Presubmission guidance: questions 45 to 56 (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
【6/6付追加更新】
Presubmission guidance: questions 1 to 11 (updated)
【6/10付追加更新】
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: document with track changes (updated)
● 以下は、その他関連参考通知
Annual re-assessment: questions and answers (updated)
Renewals: questions and answers (updated)
Post-authorisation safety studies: questions and answers (updated)
Post-authorisation efficacy studies: questions and answers (updated)
Classification of changes: questions and answers
Risk management plan (RMP): questions and answers
Transfer of marketing authorisation: questions and answers (updated)
※2016.06.10 情報更新
4/19付のGMP Platform「EMA／審査関係の更新通知（
これら通知類は「Regulatory and procedural guideline」などとして定期的に更新されます。
今般更新された通知類には下記のものがあります。
関係者にあっては、「What's New?」ウェブサイト（下記URL）
● 「What's New?」ウェブサイト
http://www.ema.europa.eu/ema/
● 個々の更新通知類
Type-IB variations: questions and answers (updated)
Type-IA variations: questions and answers (updated)
Type-II variations: questions and answers (updated)
Extension applications: questions and answers (updated)
Generic / hybrid applications: questions 35 to 43 (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
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: document with track changes (updated)
Post-authorisation measures: questions and answers (updated)
Other post-authorisation activities: questions and answers (updated)
Human post-authorisation Q&A: Introduction (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
Pre-submission queries service: questions and answers (updated)
Presubmission guidance: questions 45 to 56 (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
【6/6付追加更新】
Presubmission guidance: questions 1 to 11 (updated)
【6/10付追加更新】
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: document with track changes (updated)
● 以下は、その他関連参考通知
Annual re-assessment: questions and answers (updated)
Renewals: questions and answers (updated)
Post-authorisation safety studies: questions and answers (updated)
Post-authorisation efficacy studies: questions and answers (updated)
Classification of changes: questions and answers
Risk management plan (RMP): questions and answers
Transfer of marketing authorisation: questions and answers (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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