Adoption of the revised General Notices chapter

EDQM 10/05/2021 Strasbourg, France

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices. Overhauled to provide greater clarity for users, the structure and content of the chapter have also been reviewed. The chapter features new additions such...

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7 new reference standards and 26 replacement batches released in April 2021

EDQM 06/05/2021 Strasbourg, France

The EDQM announces the availability of: 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 26 replacement batches for Ph. Eur. reference standards.
 

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Certification monthly report of activities: April 2021

EDQM 06/05/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

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International Symposium on Plasma Supply Management: proceedings now available

EDQM 05/05/2021 Strasbourg, France

In January 2019, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) organised the International Symposium on Plasma Supply Management. This event – the first of its kind – brought together stakeholders in the blood sector to discuss...

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Tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances

EDQM 04/05/2021 Strasbourg, France

When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.

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New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids

EDQM 03/05/2021 Strasbourg, France

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).

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IMWP monographs on Favipiravir and on Favipiravir tablets published for public enquiry

EDQM 03/05/2021 Strasbourg, France

The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health...

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Subscriptions now open for the European Pharmacopoeia 10th Edition, Supplements 10.6-10.8

EDQM 29/04/2021 Strasbourg, France

The 2022 subscriptions to the European Pharmacopoeia (Ph. Eur.) are now available for sale on the EDQM WebStore. Two subscription formats are available: 1. Electronic (bilingual English/French) Users have access to the entire 10th Edition of the Ph. Eur. until 31 December 2022. For each licence...

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Risk of presence of mutagenic azido impurities in sartan active substances with a tetrazole ring

EDQM 29/04/2021 Strasbourg, France

Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested. The review of the data received,...

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New OCABR guidelines on COVID-19 recombinant spike protein vaccines and non-replicating adenovirus-vectored COVID-19 vaccines

EDQM 23/04/2021 Strasbourg, France

The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021. The...

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Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

EDQM 22/04/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete the test for “heavy metals” (HMs, general chapter 2.4.8) in monographs on substances “for veterinary use only”. The 16 monographs concerned have been published in

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.2

EDQM 21/04/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.2. The table below lists the substances affected by these revisions and for which a certificate of suitability to the Ph....

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Pharmacopoeial Discussion Group videoconference meetings - March 2021

EDQM 19/04/2021 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), held videoconferences on 6 November 2020 and on 12 March 2021. WHO (International Pharmacopoeia) participated as...

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Essential oils: revised monograph and new general chapter in the Ph. Eur.

EDQM 16/04/2021 Strasbourg, France

The 169th Session of the European Pharmacopoeia (Ph. Eur.) Commission, held in March, saw the adoption of the revised general monograph on Essential oils (2098) and of the new chapter on Monographs on essential oils (information chapter) (5.30).

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Pharmeuropa 33.2 just released

EDQM 09/04/2021 Strasbourg, France

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021.

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Certification monthly report of activities: March 2021

EDQM 08/04/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

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Full OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available

EDQM 07/04/2021 Strasbourg, France

The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. This key guideline has been in force since 12 November 2020 with the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for...

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1 new reference standard and 14 replacement batches released in March 2021

EDQM 07/04/2021 Strasbourg, France

The EDQM announces the availability of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 14 replacement batches for Ph. Eur. reference standards.

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Outcome of the 169th session of the European Pharmacopoeia Commission

EDQM 06/04/2021 Strasbourg, France

The 169th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 March 2021. At this session, the Commission adopted 68 texts for publication in Ph. Eur. Supplement 10.7, including the following 9 new texts: 8 individual monographs: Nebivolol hydrochloride (2575);...

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Adoption of the revised Raman spectroscopy chapter

EDQM 31/03/2021 Strasbourg, France

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Their interfaces are user-friendly and they can provide essential information...

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