News Archive

WHO - New collaboration between WHO International Classification of Diseases and MedDRA launched

5th July 2023

World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.

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EMA - Use of real-world evidence in regulatory decision making

4th July 2023

EMA publishes review of its studies

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EMA - Report on pharmacovigilance tasks From EU Member States

22nd June 2023

Report 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.

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EMA - Public Consultation - CTR and CTIS

21st June 2023

Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)

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EMA - Human Medicines Highlights Issue 170

20th June 2023

Issue 170, June 2023

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 June 2023

20th June 2023

Meeting Highlights

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023

20th June 2023

Meeting Highlights

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EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

20th June 2023

Building 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®.

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FDA - FDA Roundup: 16 June, 2023

20th June 2023

A roundup of FDA news

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FDA - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry

20th June 2023

This 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.

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