News Archive

EMA - Annual Report 2023

6th June 2024

Published on 30th May 2024 EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.

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EMA - Human Medicines Highlights Newsletter

6th June 2024

May 2024 The newsletter for patients, consumers and healthcare professionals

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

6th June 2024

27-30 May 2024

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

6th June 2024

21st - 22nd May 2024

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FDA - Platform Technology Designation Program for Drug Development

6th June 2024

Guidance Document available for comment

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FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections

6th June 2024

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”

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FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections

6th June 2024

Guidance document open for comment.

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FDA Roundup: 4th June 2024

6th June 2024

An at-a-glance summary of news from around the agency.

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ICH - M12 Guideline reaches Step 4 of the ICH Process

6th June 2024

The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.

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EMA - Horizon scanning on veterinary novel therapies

30th May 2024

The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.

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