News Archive

EMA - ACT EU: creating a better environment for clinical trials through collaboration

5th July 2023

ACT EU initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU).

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

5th July 2023

19-22 June 2023

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FDA Roundup - 30th June 2023

5th July 2023

An at-a-glance summary of news from around the agency:

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ICH - Reflection Paper on Harmonisation of RWE Terminology available for public consultation

5th July 2023

This Reflection Paper was endorsed by the Assembly in June 2023.

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MHRA - Corporate Plan 2023 to 2026

5th July 2023

Released 4th July 2023

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OECD - Advisory Document on GLP & Cloud Computing

5th July 2023

Supplement 1 to Document Number 17 on Application of GLP Principles to Computerised Systems

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WHO - New collaboration between WHO International Classification of Diseases and MedDRA launched

5th July 2023

World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.

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EMA - Use of real-world evidence in regulatory decision making

4th July 2023

EMA publishes review of its studies

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EMA - Report on pharmacovigilance tasks From EU Member States

22nd June 2023

Report published 22nd June 2023 Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory network to effectively respond to the pandemic. These activities are detailed in a  report published today.

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EMA - Public Consultation - CTR and CTIS

21st June 2023

Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)

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