News Archive

EMA - Reflection paper on the use of artificial intelligence in the lifecycle of medicines

20th July 2023

EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.

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EMA - public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data

20th July 2023

The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines”, co-authored by EMA, US FDA and Health Canada. This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas: Convergence on terminology for RWD and RWE Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines Registration of study protocols and reports EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment. Your input is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD/RWE in medicines regulation. Comments should be provided using this template and sent to ich@ema.europa.eu by 30 September 2023. For more details on this topic, please click here.

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023

19th July 2023

11-13 July 2023

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023

19th July 2023

3 - 6 July 2023

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EMA - Phasing out of extraordinary COVID-19 regulatory flexibilities

19th July 2023

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

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FDA - Roundup of Agency Events

19th July 2023

18th July 2023

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MHRA - Lists of products using derogations under the European Commission Directive 2022/642 Updated

19th July 2023

Lists of products using derogations under the European Commission Directive 2022/642

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MHRA - MHRA launches public consultation on reclassification of opioid-containing cough medicine

19th July 2023

Health professionals and the public have until 15 August to share their views on the potential reclassification of codeine linctus to a prescription-only medicine.

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MHRA - Thousands of unlicensed medical products seized in morning of raids in Bolton

19th July 2023

MHRA Criminal Enforcement Unit (CEU) seized a quantity of suspected unlicensed medical products following coordinated raids at three residential and six business premises in Bolton, Greater Manchester.

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EMA - Veterinary Awareness Day

10th July 2023

The EMA is organising its first-ever EMA Veterinary Awareness Day to be held on 12 and 13 September 2023.

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