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19

Gen

An Analysis Of MHRA's Latest Annual GMP Inspection Deficiencies Report

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of the data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019....[PharmaceuticalOnline] 

25

Feb

Indian drugmakers look to reduce dependence on China-made APIs

Since June 2020, India and China have seen their relations sour due to skirmishes at the border. And...

24

Feb

New Zealand seeks feedback on adopting new PIC/S Guide to GMPs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a public consultation...

24

Feb

FDA Revises Nitrosamine Guidance to Extend Recommended Timeframe for Nitrosamine Risk Assessments to March 31, 2021

To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude...

23

Feb

European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021

The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium...

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