Ten years at the service of consumer safety in Europe: over 600 analytical methods for cosmetics testing, 20 studies, 50 laboratories and more expected to join

EDQM 20/07/2020 Strasbourg, France

The experts of the European Committee for Cosmetics and Consumer Health (CD-P-COS) and the members of the Network of Official Cosmetics Control Laboratories (OCCLs) held a virtual meeting on 22 and 23 June to define steps for advancing consumer protection in Europe and for reinforcing...

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Pharmeuropa Volume 32 No. 3, July 2020

EDQM 16/07/2020 Strasbourg, France

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.3 before 30 September 2020. More information in PA/PH/CEP (20) 29.

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Pharmeuropa 32.3 just released

EDQM 15/07/2020 Strasbourg, France

All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: although draft...

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EDQM’s actions to evaluate impact of the detection of an impurity in the active substance paracetamol

EDQM 10/07/2020 Strasbourg, France

Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with...

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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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Outcome of the 167th session of the European Pharmacopoeia Commission

EDQM 07/07/2020 Strasbourg, France

The 167th session of the European Pharmacopoeia (Ph. Eur.) Commission on 23 June 2020 was the first ever to be held online, due to the COVID-19 pandemic. This unprecedented meeting successfully brought together over 130 members of the Ph. Eur. Commission, its 60 groups of experts and working...

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Past event: Keep calm and use your QMS to carry on: Tissue banking in the new normality

EDQM 06/07/2020 Strasbourg, France

As the COVID-19 pandemic begins to stabilise and we gradually return to normal daily life, it will be important to continue to ensure a safe and sufficient supply of tissues from deceased donors and to support donation and transplantation programmes. Additional measures will have to be taken to...

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European Pharmacopoeia Supplement 10.3 now available

EDQM 06/07/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.3 is now available and will be applicable in 39 European countries as of 1 January 2021.

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14 new reference standards and 18 replacement batches released in June 2020

EDQM 03/07/2020 Strasbourg, France

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

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Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020

EDQM 01/07/2020 Strasbourg, France

Published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C describes a test for bacterial endotoxins (BET) that can be used as an alternative to the classic limulus amoebocyte lysate (LAL)-based methods...

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“EDQM Highlights – 2019 annual report” published

EDQM 30/06/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s 2019 annual report is now available, providing a comprehensive overview of our activities in 2019 and information on our achievements and events. We support health systems at national level and help protect patients by enabling...

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Elemental impurities in plastic materials: extension of Pharmeuropa commenting period for chapter 2.4.35

EDQM 26/06/2020 Strasbourg, France

Due to high public interest and the importance of the text, it has been decided to extend the consultation period for the new general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) to give stakeholders more time to comment. Originally published in Pharmeuropa...

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Vacancy Notice - Scientific Assistants

EDQM 23/06/2020 Strasbourg, France

Grade: B4 Salary: from €4 100/month Contract Type: Full time fixed term contract – up to a maximum of 5 years Location: Strasbourg (France) Reference: Vacancy Notice n° e 20/2020 ...

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Ph. Eur. Commission consults stakeholders on revised Raman spectroscopy chapter

European Pharmacopoeia Department (EPD) 22/06/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking feedback on revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Offering user-friendly interfaces and rapid, non-destructive measurements generating essential information...

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Oxygen 98%: Ph. Eur. receives valuable feedback on new oxygen quality

EDQM 15/06/2020 Strasbourg, France

The EDQM would like to warmly thank its stakeholders for their invaluable feedback and their commitment to the work of the European Pharmacopoeia (Ph. Eur.). About 40 different interested parties, including gas producers and industry associations, National Pharmacopoeia Authorities (NPAs),...

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EDQM continues to support COVID-19 vaccine developers by providing selected training materials

EDQM 11/06/2020 Strasbourg, France

Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts (see “ EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe”), the EDQM has compiled a companion list of training materials on the European Pharmacopoeia...

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Impact of COVID-19 crisis – National authorities in Europe report shortages of medical products and increase in illegal activities

EDQM 09/06/2020 Strasbourg, France

The Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) held its spring meeting via videoconference from 26 to 28 May 2020. Some 35 delegates from 24 countries participated. A dedicated discussion took place to...

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EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe

EDQM 08/06/2020 Strasbourg, France

The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards. The EDQM and the...

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7 new Ph. Eur. reference standards and 14 replacement batches released in May 2020

EDQM 04/06/2020 Strasbourg, France

New releases Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Change of price Change of EDQM storage/shipping conditions Change in the policy for withdrawing reference standards from sale Current non-availability See also: Content of the Ph. Eur....

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Annual OMCL Network meeting focuses on role of OMCLs during the COVID-19 pandemic

EDQM 28/05/2020 Strasbourg, France

The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the EDQM. The...

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