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EMA - New recommendations to strengthen supply chains of critical medicines

24th April 2024

EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.

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FDA - Data Standards Catalog - Open for Comments

24th April 2024

Released April 2024

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FDA Roundup - 23rd April 2024

24th April 2024

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

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MHRA - Notify MHRA about a clinical investigation for a medical device - Guidance Updated

24th April 2024

Information for manufacturers added.

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MHRA - RegulatoryConnect

24th April 2024

The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.

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WHO - launch of first ever Patient Safety Rights Charter

24th April 2024

It is the first Charter to outline patients’ rights in the context of safety, and will support stakeholders in formulating the legislation, policies and guidelines needed to ensure patient safety.

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EMA - Revised CTIS transparency rules will become applicable on 18 June 2024

22nd April 2024

Launch of a new version of the CTIS public portal.

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EMA - Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products

18th April 2024

Consultation ended 25MAR2024

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EMA - Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1

18th April 2024

Consultation end: 31MAY2024

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EMA - Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water

18th April 2024

Annex on compatibility studies between veterinary medicinal products and biocidal products.

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