7 new reference standards and 23 replacement batches released in October 2019

EDQM 04/11/2019 Strasbourg, France

The EDQM announces: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability Content of the Ph. Eur. RS catalogue How to place an RS order   7 New Ph. Eur....

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Warning: Phishing campaign

EDQM 04/11/2019 Strasbourg, France

A phishing campaign has been launched from the internet by impersonating an EDQM user in e-mails aimed at infecting the recipients’ computers. These e-mails have been sent from outside the EDQM’s infrastructure, which is why the EDQM has no control over them. They have no connection with the...

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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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Sign up today! FREE training on the “Management of Extraneous Agent in IVMPs”

EDQM 23/10/2019 Strasbourg, France

To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the content of the training webinars which took place on 1 April 2020.

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Ph. Eur.: new approach to extraneous agents testing of IVMPs

EDQM 23/10/2019 Strasbourg, France

The European Pharmacopoeia Commission adopted 43 texts related to its new approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs). From starting material to final product, users will now have to follow an overall risk-management approach to ensure they...

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Pharmeuropa 31.4 just released

EDQM 11/10/2019 Strasbourg, France

All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts. It should be noted that: Although draft monographs must not be regarded as official standards, they will, once...

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European Pharmacopoeia Supplement 10.1 available now

EDQM 11/10/2019 Strasbourg, France

Supplement 10.1 of the European Pharmacopoeia is now available; it will be applicable in 38 European countries as of 1 April 2020. This volume is included in the 2020 subscription to the 10th Edition of European Pharmacopoeia (covering supplements 10.0, 10.1 and 10.2). This subscription is...

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Just released: Newsletter Transplant 2019

EDQM 10/10/2019 Strasbourg, France

The EDQM/Council of Europe publishes Newsletter Transplant, which gives data on organ, tissue and cell donation and transplantation at the European and international levels. This work is co-ordinated by the Spanish National Transplant Organisation (ONT), which analyses the data collected through...

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EDQM: transparency and dialogue are key in achieving pharmacopoeial harmonisation

EDQM 08/10/2019 Strasbourg, France

On the occasion of the 30th Anniversary of the Pharmacopoeial Discussion Group (PDG), Susanne Keitel, Director of the EDQM, highlighted the progress achieved by the Group towards pharmacopoeial harmonisation and its key role in reducing the need for redundant testing by manufacturers, hence...

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15 new reference standards and 16 replacement batches released in September 2019

EDQM 03/10/2019 Strasbourg, France

The EDQM announces the availability of: 15 New Ph. Eur. reference standards: Catalogue code Name Unit Quantity Y0002139 Zolpidem for system suitability CRS 10 mg Y0002140 Almotriptan for system suitability CRS 10 mg Y0002144 Almotriptan malate CRS 70 mg Y0002145 Testosterone impurity I CRS 20 mg...

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Delays in treatment of requests for revision and renewal of CEPs

EDQM 30/09/2019 Strasbourg, France

The EDQM is currently having some difficulty in achieving the assessment times for revisions and renewals of CEP applications - both initial requests and assessment of responses to requests for information. The delay is currently around 5 weeks (i.e. the outcome of the assessment is being...

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New Guide to the quality and safety of tissues and cells for human application

EDQM 20/09/2019 Strasbourg, France

The EDQM has just released the new edition of its Guide to the quality and safety of tissues and cells for human application. This 4th edition provides healthcare professionals with an extensive overview of the most recent advances in the field, as well as technical guidance to ensure the quality...

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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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The European Pharmacopoeia: pioneer of good health in Europe. “Memories of a European pharmacist” by Fernand Sauer

EDQM 05/09/2019 Strasbourg, France

The Council of Europe has played a pioneering role in a number of fields, some better known to the public than others. One such area is medicines and healthcare, with the creation of the European Pharmacopoeia 55 years ago. Today, the Pharmacopoeia is certainly a success story for the Council of...

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2 new reference standards and 18 replacement batches released in August 2019

EDQM 05/09/2019 Strasbourg, France

The EDQM announces the availability of: 2 New Ph. Eur. reference standards: Catalogue code Name Unit Quantity Y0002173 Tilidine hydrochloride hemihydrate - * narc 20 mg Y0002172 Tilidine for system suitability - * narc 10 mg   18 Replacement batches for Ph. Eur. reference standards: Catalogue...

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Ph. Eur. 10th Edition - Now available!

EDQM 03/09/2019 Strasbourg, France

The 10th Edition of the European Pharmacopoeia, which is applicable in 38 European countries from 1 January 2020 and is used in over 100 countries worldwide, is now available! The 2020 subscription consists of 3 initial volumes (10.0) already published and the first 2 cumulative updates: 10.1...

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European Organ Donation Day 2019 – Discover the programme!

EDQM 30/08/2019 Strasbourg, France

The EDQM/Council of Europe organises the European Day for Organ Donation and Transplantation (EODD) every year in a different country to raise awareness on the importance of organ donation, as a way of saving and improving lives. This year, EODD will be celebrated on Saturday, 12 October 2019 in...

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11 new reference standards and 28 replacement batches released in July 2019

EDQM 06/08/2019 Strasbourg, France

The EDQM announces the availability of: 11 new Ph. Eur. reference standards: Catalogue code Name Unit Quantity Y0002134 Topiramate 70 mg Y0002133 Topiramate impurity A 20 mg Y0002132 Topiramate impurity E 40 mg Y0002115 Benserazide for peak identification A 10 mg Y0002102 Fenoterol for system...

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Certification procedure: revised documents July 2019

EDQM 17/07/2019 Strasbourg, France

The EDQM has revised the following documents to reflect current practice and clarify a couple of items:  - Terms of reference;  - Code of Practice for the Certification procedure.

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As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications

EDQM 15/07/2019 Strasbourg, France

According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications....

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