Últimas noticias
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.
Added in February 26 February …
Added in February 26 February NEW - 23-25 January 2024 CMDh minutes 20 February NEW - 20-21 February 2024 CMDh agenda
Summary of CMDh activities 2023…
Summary of CMDh activities 2023
Added in March 11 March PSUR…
Added in March 11 March PSUR Summary Assessment Report for Yimmugo
ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” Training Material is now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” Training Material.
Member: Örn Gudmundsson…
Member: Örn Gudmundsson Alternate: Ragnhildur Heidarsdottir Iceland Medicines Agency Vinlandsleid 14 113 Reykjavik Iceland
The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process
The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024.
ICH E2D(R1) draft Guideline reaches Step 2 of the ICH process
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” has reached Step 2 of the ICH process on 5 February 2024.
This page lists the current…
This page lists the current members and alternates of the Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh). For more information, see European expert declaration of interests and professional qualifications. For contact details, please [...]
Diphtheria, Tetanus, Inactivated…
Diphtheria, Tetanus, Inactivated Poliomyelitis vaccine End of procedure: 18/08/2023 Date of publication: 31/01/2024
CMDH PRESS RELEASES 2024
Report from the meeting held on 19-20 March 2024 Report from the meeting held on 20-22 February 2024 Report from the meeting held on 23-24 January 2024
Member: Petra Gubová Alternate:…
Member: Petra Gubová Alternate: Kristína Ráczová State Institute for Drug Control Kvetná 11 SK-825 08 BRATISLAVA 26