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News Archive
MHRA - Guidance on Medical devices: software applications (apps)
14th September 2022MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
14th September 2022MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
EMA - Comments received on ICH guideline Q14 on analytical procedure development
8th September 2022EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development
EMA - Comments received on ICH guideline on Q2(R2) Validation of analytical procedures
8th September 2022The EMA have published an overview of the comments received for on ICH guideline on Q2(R2) Validation of analytical procedures.
EMA - Key performance indicators (KPIs) to monitor the European clinical trials environment
31st August 2022This 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.
FDA - Draft Guidance on Charging for Investigational Drugs Under an IND
31st August 2022Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE
EMA - Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
30th August 2022The 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).
FDA - Q9(R1) Quality Risk Management (Draft Guidance Document)
30th August 2022Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system.
MHRA Blog - Innovation, Quality & Transparency – a Compliance Team 1 Perspective
30th August 2022There has been much discussion of late between regulators and industry on how we can ensure that patients and the public get new medicines as quickly as possible - all the way from development to regulatory approval - while still ensuring they are safe, effective and of the required quality.
OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
30th August 2022OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
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