※追記更新（2016.08.09）
6/3付(6/7付及び6/10付で追記更新)のGMP Platformトピック「EMA／審査関係の更新通知（2016年6月付） 」の8月付更新通知に相当するものが、8/3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。
6/3付(6/7付及び6/10付で追記更新)のGMP Platformトピック「EMA／審査関係の更新通知（201
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。
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
● 個々の更新通知類
Type-IA variations: questions and answers (updated)
Type-IB variations: questions and answers (updated)
Type-II variations: questions and answers (updated)
Transfer of marketing authorisation: questions and answers (updated)
Post-authorisation safety studies: questions and answers (updated)
Guideline on the processing of renewals in the centralised procedure: document with track changes , draft: consultation closed (updated)
Renewals: Regulatory and procedural guidance (updated)
Presubmission guidance: questions 24 to 33 (updated)
Presubmission guidance: questions 1 to 11 (updated) 本通知は7/27付
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
Transparency: questions and answers (updated)
Extension applications: questions and answers (updated)
Grouping of variations: questions and answers (updated)
Worksharing: questions and answers (updated)
Generic / hybrid applications: questions 1 to 10 (updated)
Generic / hybrid applications: questions 11 to 22 (updated)
Pre-submission: Regulatory and procedural guidance (updated)
Application and Evaluation: Regulatory and procedural guidance (updated)
Guideline on the processing of renewals in the centralised procedure , adopted
Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (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)
Renewals: questions and answers (updated)
Type-IB variations: questions and answers (updated)
Type-II variations: questions and answers (updated)
Transfer of marketing authorisation: questions and answers (updated)
Post-authorisation safety studies: questions and answers (updated)
Guideline on the processing of renewals in the centralised procedure: document with track changes , draft: consultation closed (updated)
Renewals: Regulatory and procedural guidance (updated)
Presubmission guidance: questions 24 to 33 (updated)
Presubmission guidance: questions 1 to 11 (updated) 本通知は7/27付
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
Transparency: questions and answers (updated)
Extension applications: questions and answers (updated)
Grouping of variations: questions and answers (updated)
Worksharing: questions and answers (updated)
Generic / hybrid applications: questions 1 to 10 (updated)
Generic / hybrid applications: questions 11 to 22 (updated)
Pre-submission: Regulatory and procedural guidance (updated)
Application and Evaluation: Regulatory and procedural guidance (updated)
Guideline on the processing of renewals in the centralised procedure , adopted
Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (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)
Renewals: questions and answers (updated)
【8/9付追記更新】
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
Presubmission guidance: questions 24 to 33 (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
Presubmission guidance: questions 24 to 33 (updated)
執筆者について
古田土 真一
経歴
GMDPコンサルタント（Pharmaceutical Quality Science Advisor） 1979年より田辺製薬(株)(現田辺三菱製薬)にて合成探索研究、プロセス・工業化研究、CMCプロジェクト開発、治験薬QA、コーポレートQAを歴任。2008年より武州製薬(株)にてQA/QCの管理監督。2009年より中外製薬(株)にて治験薬・医薬品のQA業務・品質システムを改革推進。2013年よりアステラス・アムジェン・バイオファーマ(株)にてCMC・Supply Chain・QAの長として業務構築。2015年より三井倉庫ホールディングス(株)にてヘルスケア製品の事業開発アドバイザーとして業務構築。2015年9月より (国立研究開発法人) 国立精神・神経医療研究センター／トランスレーショナル・メディカルセンター臨床研究支援部アドバイザーとして医薬品開発を、また2022年11月からジェダイトメディスン(株)の品質アドバイザーとして医薬品上市を支援中。
医薬品の開発から上市・保管・流通までを品質の側面から一貫した経験を活かし、GMDPコンサルタントとしてGood Practicesの支援依頼に対応中。
コメント
/
/
/
この記事へのコメントはありません。
コメント