News Archive

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022

14th September 2022

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022

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FDA - Computer Software Assurance for Production and Quality System Software

14th September 2022

Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.

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MHRA - new conflicts of interest code of practice for independent advisors

14th September 2022

MHRA - new conflicts of interest code of practice for independent advisors

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MHRA - Guidance on Medical devices: software applications (apps)

14th September 2022

MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'

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MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees

14th September 2022

MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees

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EMA - Comments received on ICH guideline Q14 on analytical procedure development

8th September 2022

EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development

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EMA - Comments received on ICH guideline on Q2(R2) Validation of analytical procedures

8th September 2022

The EMA have published an overview of the comments received for on ICH guideline on Q2(R2) Validation of analytical procedures.

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EMA - Key performance indicators (KPIs) to monitor the European clinical trials environment

31st August 2022

This report provides an overview of Key Performance Indicators (KPIs) related to the implementation of the CTR. The Clinical Trials Regulation Metrics report is published on a monthly basis starting in May 2022.

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FDA - Draft Guidance on Charging for Investigational Drugs Under an IND

31st August 2022

Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE

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EMA - Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan

30th August 2022

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the PDF icon 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).

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