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News Archive
EMA - Report on pharmacovigilance tasks From EU Member States
22nd June 2023Report published 22nd June 2023 Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory network to effectively respond to the pandemic. These activities are detailed in a report published today.
EMA - Public Consultation - CTR and CTIS
21st June 2023Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)
EMA - Human Medicines Highlights Issue 170
20th June 2023Issue 170, June 2023
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 June 2023
20th June 2023Meeting Highlights
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023
20th June 2023Meeting Highlights
EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use
20th June 2023Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®.
FDA - FDA Roundup: 16 June, 2023
20th June 2023A roundup of FDA news
FDA - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry
20th June 2023This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.
MHRA - Implementation of medical devices future regime
20th June 2023The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
MHRA - New lay commissioner appointed to the Commission on Human Medicines
20th June 2023Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative.
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