News Archive

ECA - New Guide on GMP Compliant Equipment Design

5th April 2023

The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.

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ICH - Q9 QRM Revision reaches step 4

5th April 2023

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.

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EMA - DARWIN EU® has completed its first studies and is calling for new data partners

29th March 2023

DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines.

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023

29th March 2023

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023

29th March 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023

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MHRA - MHRA good clinical practice (GCP) metrics reports

29th March 2023

MHRA good clinical practice (GCP) metrics reports of compliance issues, 2019-2020

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UKRI - equality, diversity and inclusion strategy

29th March 2023

UKRI has published the first edition of its EDI strategy, which outlines our ambition for a thriving research and innovation system, by everyone, for everyone.

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EMA - Mid-point Report Published

27th March 2023

EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.

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EDQM - CEP 2.0

23rd March 2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking input from Certification of suitability (CEP) users for the implementation of the CEP 2.0.

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EMA - Guideline on computerised systems and electronic data in clinical trials

22nd March 2023

This guideline replaces the 'Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials' (EMA/INS/GCP/454280/2010).

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