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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 (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were published on 13 November 2020 on the EMA’s website. The revision concerns a rewording of the “Production” section and deletion of the N-nitrosamines test section.



These revised monographs were not published in Pharmeuropa for public enquiry as the changes made are in line with the CHMP recommendations. In addition, to ensure that the implementation date for the Ph. Eur. requirements is aligned with regulatory decisions as much as possible, the Ph. Eur. Commission has decided to publish the monographs under the rapid-revision procedure. The implementation date for the five revised monographs has therefore been set as 1 April 2021. The PDF versions of these monographs can be downloaded from the EDQM website. The revised monographs have been added to the online and downloadable versions of Supplements 10.4 and 10.5. They will be included in the printed version from Supplement 10.6....[EDQM]

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...

22

Feb

EMA nitrosamine impurities in medicines Update

An implementation plan agreed in February 2021 sets out how the 

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