Últimas noticias
Added in July 2024 2 July NEW…
Added in July 2024 2 July NEW - 28-29 May 2024 CMDh minutes
Member: Jascha Johann Hörnisch…
Member: Jascha Johann Hörnisch Alternate: Ursula Ladstaedter BASG/AGES Traisengasse 5 1200 Wien, Austria
Press Release: ICH Assembly Meeting, Fukuoka, Japan, June 2024
The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH [...]
Added in June 2024 5 June NEW…
Added in June 2024 5 June NEW - 23-25 April 2024 CMDh minutes NEW - Report from the meeting held on 28-29 May 2024 UPDATE - The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF) UPDATE - Data [...]
The ICH M12 Guideline reaches Step 4 of the ICH Process
The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.
ICH M14 draft Guideline reaches Step 2 of the ICH process
The ICH M14 draft Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” has reached Step 2 of the ICH process on 21 [...]
The ICH Q2(R2)/Q14 Introductory Training Presentation is now available on the ICH website.
Following the adoption of the Q2(R2) and Q14 Guidelines, a Step 4 Introductory Training Presentation has been developed by the Q2(R2)/Q14 Expert Working Group.
Member: Tea Linhola Alternate:…
Member: Tea Linhola Alternate: Paulina Ikäheimo Finnish Medicines Agency P.O. Box 55 FI-00034 FIMEA
Template for Applicant’s responses…
Template for Applicant's responses to the questions raised by RMS and CMSs Applicant's response template (September 2023)
Member: vacant Alternate: Neringa…
Member: vacant Alternate: Neringa Kalinauskaite State Medicines Control Agency Žirmūnų str.139A 09120 Vilnius LITHUANIA
Added in May 2024 27 May NEW -…
Added in May 2024 27 May NEW - 28-29 May CMDh agenda 2 May NEW - Report from the meeting held on 23-25 April 2024 UPDATE - Request for MRP/RUP / Update assessment report NEW - Art [...]
Added in April 2024 3 April …
Added in April 2024 3 April UPDATE - Q&A on Pharmacovigilance Legislation NEW - Procedural advice on Zero Day MR Procedures NEW - Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication [...]
Verorab (rabies virus,…
Verorab (rabies virus, inactivated) End of procedure: 17/01/2024 Date of publication: 03/04/2024
Procedural advice on Zero Day MR…
Procedural advice on Zero Day MR Procedures (March 2024)
Palexia and associated names…
Palexia and associated names (tapentadol hydrochloride) DE/W/083/pdWS/001 End of Procedure: 01/07/2014 Date of Publication: 09/10/2014 DE/W/083/pdWS/002 End of Procedure: 15/12/2014 Date of Publication: 30/01/2015 DE/W/123/pdWS/001 End of Procedure: 10/12/2019 Date of Publication: 09/03/2020 DE/W/124/pdWS/001 End [...]
ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management»
The ICH Secretariat is pleased to announce the publication of the ICH Q12 “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management Introductory Video” following the publication of the ICH Q12 Module 8 in February [...]
Core SmPC/PL – EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines
EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines
Template – PSUR Assessment…
Template - PSUR Assessment Report (March 2017, correction February 2024)
The ICH E2D(R1) draft Guideline presentation available now on the ICH website
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the [...]
The ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management” Module 8 Training Material is now available on the ICH Website.
The ICH Secretariat is pleased to announce the publication of ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management” Module 8 Training Material.