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...

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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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Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)

EDQM 27/03/2020 Strasbourg, France

The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised...

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EDQM website search engine deactivated

EDQM 02/03/2020 Strasbourg, France

The EDQM regrets to inform its users that the search engine on its website has been deactivated and is currently unavailable for technical reasons. We are aware of this recurring issue and are working on a long-term solution. We therefore request that our users refrain from contacting the EDQM...

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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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Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines

EDQM 29/10/2019 Strasbourg, France

Since July 2018, EDQM has been actively involved in activities related to the detection and control of nitrosamine impurities in sartan active substances (APIs) with a tetrazole ring for which there are CEPs. These activities have included contacting CEP holders to request data and corrective...

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EDQM’s actions to evaluate impact of impurity in ranitidine medicines

EDQM 16/09/2019 Strasbourg, France

The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers. An impurity called N-nitrosodimethylamine (NDMA) was detected in some of these medicines. Last week, the European Medicines Agency (EMA) announced that it was starting a review of medicines...

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First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)

EDQM 03/04/2019 Strasbourg, France

Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major...

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Update on the review of CEP applications for sartans (18 January 2019)

EDQM 18/01/2019 Strasbourg, France

Following new information received recently by EDQM about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions will have been implemented by the relevant company:...

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