News Archive

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FDA - Draft Guidance on Charging for Investigational Drugs Under an IND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Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE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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FDA - Q9(R1) Quality Risk Management (Draft Guidance Document)

30th August 2022

Risk 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.

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MHRA Blog - Innovation, Quality & Transparency – a Compliance Team 1 Perspective

30th August 2022

There 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.

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OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP

30th August 2022

OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP

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OECD - Position Paper on Quality Improvement Tools and GLP

30th August 2022

OECD - July 2022 Position Paper on Quality Improvement Tools and GLP

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MHRA - Decommission of eSUSAR

5th August 2022

The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products.

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EDQM - Stakeholder consultation – Draft guidelines for medication review

3rd August 2022

Stakeholder Consultation

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EMA - Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making

3rd August 2022

EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).

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