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05

Nov

EMA - Guidance on the application of the amended Variations Regulation from 1 January 2025

The European Medicines Agency has updated its guidance documents for companies on the submission of variations to marketing authorizations (MAs) in preparation for 1 January 2025, when the provisions of the amended EU Variations Regulation are due to apply...[EMA]

14

Gen

US FDA CDER’s work to help develop a nitrosamines acceptable intake limit approach

In the Spotlight on CDER Science, CDER experts work with international regulators to develop a methodology,...

14

Gen

China publishes guidelines in push to reform regulations by 2027

he Chinese government has published guidelines intended to accelerate the reform of drug and medical...

14

Gen

ndia’s CDSCO gives small manufacturers more time to comply with new GMP rules

India’s Central Drugs Standard Control Organization (CDSCO) has given small and medium scale manufacturers...

07

Gen

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

The U.S. Food and Drug Administration issued draft guidance to provide recommendations on the...

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