News Archive

EMA - Human Medicines Newsletter, Jan 23

19th January 2023

EMA - Human Medicines Newsletter, January 23

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EMA - SME Newsletter Jan 2023

19th January 2023

EMA - SME Newsletter Jan 2023

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FDA - Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

19th January 2023

FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

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FDA - FDA Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical GMP

19th January 2023

FDA have signed an Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice.

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MHRA - Horizon Scanning Case Study

19th January 2023

MHRA - Horizon Scanning Case Study

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MHRA - MHRA increases UK assessment capacity for in-vitro diagnostic devices

19th January 2023

MHRA increases UK assessment capacity for in-vitro diagnostic devices

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MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group

19th January 2023

MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group

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EMA: Facilitating Decentralised Clinical Trials in the EU

11th January 2023

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).

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EMA: Virtual Public CTIS Event

11th January 2023

The EMA are holding a virtual public CTIS event “CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023”.

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022

21st December 2022

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022

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