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News Archive
MHRA - E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
9th February 2022MHRA E-learning modules: medicines, updated
MHRA - Guidance Oversight and monitoring activities
9th February 2022MHRA Guidance - Oversight and monitoring activities
MHRA - Guidance Risk-Adapted Approach to clinical trials and Risk Assessments
9th February 2022Guidance - Risk-Adapted Approach to clinical trials and Risk Assessments
MHRA - Public Consultation on new Clinical Trials Legislation
9th February 2022Public Consultation on new Clinical Trials Legislation
MHRA - Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response
9th February 2022Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response
EMA - Press release and press briefing on CTR/CTIS go-live
26th January 2022On 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.
EC - Safety Assessment of Clinical Trials
25th January 2022To 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.
EMA - Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs - Joint Press Release
25th January 2022The 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).
EMA - CTIS - New Version of the Sponsor Handbook
25th January 2022Ahead of the go-live date of 31st January 2022, EMA have published a Sponsor Handbook.
EMA - Global regulators discuss path towards regulatory alignment on response to Omicron variant
25th January 2022Global regulators discuss path towards regulatory alignment on response to Omicron variant
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