New strategy for N-nitrosamine impurities in Ph. Eur. monographs

EDQM 22/01/2024 Strasbourg, France

At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...

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Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies

EDQM 08/09/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an...

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N-nitrosamine impurities in Ph. Eur. monographs: update on approach

EDQM 24/07/2023 Strasbourg, France

Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...

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Important update on N-nitrosamine impurities in substances covered by CEPs

EDQM 21/07/2023 Strasbourg, France

On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...

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CEP holders – How to submit a nitrosamine risk assessment

EDQM 30/01/2023 Strasbourg, France

To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Minor revisions should be submitted for revised...

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Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines

EDQM 06/01/2023 Strasbourg, France

At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine...

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OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines

EDQM 31/05/2022 Strasbourg, France

In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...

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New EDQM website, redesigned to better serve your needs – Now online!

EDQM 01/04/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...

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

EDQM 17/03/2021 Strasbourg, France

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...

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General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs

EDQM 17/03/2021 Strasbourg, France

In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was...

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Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation

EDQM 01/03/2021 Strasbourg, France

The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the...

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Nitrosamines – Update from the CEP procedure

EDQM 16/12/2020 Strasbourg, France

In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020...

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Seven new reference standards available for the analysis of N-nitrosamine impurities

EDQM 14/12/2020 Strasbourg, France

To support the implementation of the newly adopted general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42., previously listed as 2.4.36.), seven reference standards have been established and are available from the European Directorate for the Quality of Medicines...

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Ph. Eur. Commission adopts a new general chapter for the analysis of N-nitrosamine impurities

EDQM 07/12/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36). The general chapter should be seen as an analytical toolbox that proposes three procedures relying on more or...

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Nitrosamines risk assessment: update for CEP holders

EDQM 17/08/2020 Strasbourg, France

In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the...

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Last chance to comment: analysis of N-nitrosamine impurities

EDQM 10/07/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020. Given the exceptional circumstances due...

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Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-nitrosamines

EDQM 07/04/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36). In line with the Decision of the European Commission on 2 April 2019 (Annex I to the European Commission Decision C(2019) 2698 final) and...

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Nitrosamine contamination: new web page on EDQM response

EDQM 28/01/2020 Strasbourg, France

A new web page providing centralised access to all information related to nitrosamine contamination is now available on the EDQM website. It presents a general overview of the issue and provides details of the actions taken in the different sectors of activity concerned: the European...

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Detection of N-nitrosamine impurities: the Ph. Eur. launches a public consultation on the revised general monograph Substances for pharmaceutical use (2034)

EDQM 13/12/2019 Strasbourg, France

The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under...

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EDQM launches a new HelpDesk

EDQM 21/11/2019 Strasbourg, France

As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer...

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