25 New batches of Ph. Eur. Reference Standards released

EDQM 13/07/2018 Strasbourg, France

New Ph. Eur. Reference Standards     Access the full list here       Content of the European Pharmacopoeia catalogue The catalogue of the European Pharmacopoeia (Ph. Eur.) offers a portfolio of more than 2 800 reference standards. This Catalogue is updated on a daily basis and gives access not...

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Ph.Eur. Supplement 9.6 available now

EDQM 10/07/2018 Strasbourg, France

The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.

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New monograph on Sulfobutylbetadex sodium (2804)

EDQM 10/07/2018 Strasbourg, France

The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6. Variability in the molecular mass related to the range of degree of substitution covered by this monograph has justified the immediate revision of the text to enlarge the content limits from 98.0-102.0% to...

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Outcome of the 161st Session of the European Pharmacopoeia Commission

EDQM 29/06/2018 Strasbourg, France

At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and 7 revised chapters; new texts include: four monographs elaborated under the P4 procedure: Nilotinib...

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EDQM publishes a new section dedicated to biotherapeutics on its website

EDQM 29/06/2018 Strasbourg, France

The new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the...

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International conference on the EDQM/European Pharmacopoeia, June 2019

EDQM 20/06/2018 Strasbourg, France

SAVE THE DATE! International conference on the EDQM/European Pharmacopoeia on 19-20 June 2019, Strasbourg, France To celebrate the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th anniversary of the establishment of the European Network of Official Medicines...

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World Blood Donor Day, 14 June 2018: "Be there for someone else. Give Blood. Share Life"

EDQM 13/06/2018 Strabourg, France

June 14 is World Blood Donor Day! Let’s celebrate together! A, B, 0: some letters are more important than one may think... Join the EDQM in supporting the World Blood Donor Day.   Giving blood saves lives. Every year more than 25 million...

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New building will ensure continuity in pharmaceutical reference standards supply

EDQM 12/06/2018 Strasbourg, France

The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in...

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New Ph. Eur. Reference Standards released in May 2018

EDQM 07/06/2018 Strasbourg, France

New Ph. Eur. Reference Standards Y0001946 Platycodin D CRS Y0001969 Etanercept CRS Y0001957 Platycodon root dry extract for system suitability HRS Access the full list here     Content of the European Pharmacopoeia catalogue The catalogue of the European Pharmacopoeia (Ph. Eur.) offers a...

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Monograph for Water, highly purified (1927) to be suppressed from the European Pharmacopoeia

EDQM 05/06/2018 Strasbourg, France

Following a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph...

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OMCLs discuss Brexit and updates to medicines’ testing methods at annual meeting

EDQM 25/05/2018 Strasbourg, France

The Annual Meeting of the Official Medicines Control Laboratories (OMCLs) took place on 14-18 May in Sarajevo (Bosnia and Herzegovina). It was attended by 230 participants from 38 countries, representing 65 official laboratories and including a representative of the OMCL Network, the Taiwan Food...

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Towards harmonisation in the classification of medicines across Europe

EDQM 23/05/2018 Strasbourg, France

The Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on...

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New EDQM guideline "How to read a CEP"

EDQM 22/05/2018 Strasbourg, France

EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the...

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European and Indian Pharmacopoeias to cooperate further on provision of strong quality standards for medicines

EDQM 15/05/2018 Strasbourg, France

The EDQM/European Pharmacopoeia (Ph. Eur.) and the Indian Pharmacopoeia Commission (IPC) held a symposium in Mumbai to discuss the quality control of medicines in the context of the pharmaceutical legislation and regulatory requirements that exist in Europe and India. The event was attended by...

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Pharmeuropa Volume 30 No 2, april 2018

EDQM 15/05/2018 Strasbourg, France

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.2 before 30 June 2018. More information in document PA/PH/CEP (18) 23.

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Replacement, Reduction, Refinement (3Rs) - activities of the Ph. Eur. Commission in the last decade

EDQM 11/05/2018 Strasbourg, France

Since the opening for signature of the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes in 1986, the European Pharmacopoeia Commission and its experts have made significant progress in Replacing, Reducing, Refining (3Rs) the use of...

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New Ph. Eur. Reference Standards released in April 2018

EDQM 11/05/2018 Strasbourg, France

5 new Ph. Eur. Reference Standards (RS) were released in April 2018

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European Day for Organ Donation and Transplantation (EODD) 2018: awareness campaign starts

EDQM 09/05/2018 Strasbourg, France

Fin 2016, au sein des 47 États membres du Conseil de l’Europe, plus de 142 000 patients étaient en attente d’une transplantation rénale, hépatique, cardiaque, pulmonaire, pancréatique ou intestinale, et, en moyenne, 19 d’entre eux mouraient chaque jour dans l’attente d’un organe qui n’arrivait...

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Report on the International API inspection programme published

EDQM 24/04/2018 Strasbourg, France

As part of the Certification of Suitability procedure, the EDQM runs an inspection programme for API manufacturers and is committed to optimise the inspection resources as much as possible. Therefore it has been an active member of the International API Inspection Programme since its creation...

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