News Archive

EMA - Press release and press briefing on CTR/CTIS go-live

26th January 2022

On 25 January 2022, the European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) published a press release and held a joint press briefing to provide an update on the application of the Clinical Trial Regulation, and the go-live of the Clinical Trials Information System (CTIS) on 31st January 2022.

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EC - Safety Assessment of Clinical Trials

25th January 2022

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. A risk-based approach should define the frequency of screening of safety information, the extent of its assessment and the timelines of assessment and reporting.

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EMA - Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs - Joint Press Release

25th January 2022

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are coming together to optimise the environment for clinical research in Europe by launching Accelerating Clinical Trials in the EU (ACT EU).

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EMA - CTIS - New Version of the Sponsor Handbook

25th January 2022

Ahead of the go-live date of 31st January 2022, EMA have published a Sponsor Handbook.

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EMA - Global regulators discuss path towards regulatory alignment on response to Omicron variant

25th January 2022

Global regulators discuss path towards regulatory alignment on response to Omicron variant

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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022

25th January 2022

Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022

25th January 2022

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022

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EMA - Open for Comments Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

25th January 2022

In December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website.

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EMA - Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched

25th January 2022

Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched

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FDA - FDA publishes 2021 Year in Review

25th January 2022

FDA Year in Review 2021

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