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News Archive
EMA - CTIS newsflash – 12 May 2023
17th May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Human Medicines Highlights Newsletter 169
17th May 2023Edition 169
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
17th May 2023Highlights from 10 - 12 May 2023 meeting
EMA - eAF-PMS NEWSLETTER 3
17th May 2023News, views and interviews for the informed stakeholder. Published four times a year by the European Medicines Agency
EMA - recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact
17th May 2023EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.
MHRA - Medical device stand-alone software including apps
17th May 2023MHRA have updated 'Medical device stand-alone software including apps' to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
WHO - calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs)
17th May 2023The World Health Organization (WHO) is calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs) to protect and promote human well-being, human safety, and autonomy, and preserve public health.
EMA - CTIS newsflash
10th May 20235 May 2023
EMA - Questions and Answers about the raw data proof-of-concept pilot for industry
10th May 2023Scope, terms of participation and data submission process
EMA - Review of transparency rules for the EU Clinical Trials Information System (CTIS)
10th May 2023EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.
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