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 * Home
 * About us
   * About us
   * What's new?
     * All News
     * EDQM response to COVID-19
     * EDQM response to nitrosamine contamination
     * Past News
     * All Events
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     * Safety
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     * History
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     * Employment opportunities
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     * ISO 17025
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   * What's new?
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     * EDQM response to COVID-19
     * EDQM response to nitrosamine contamination
     * Events
   * The Ph. Eur. work programme
     * Elaborations & Revisions
     * Where to find: the Knowledge database
     * The Ph. Eur. work programme
   * Pharmacopoeial Harmonisation
     * International harmonisation
     * Harmonisation status for Excipient monographs (PDG)
     * Harmonisation status for General Texts (PDG)
   * The European Pharmacopoeia (Ph. Eur.)
     * Background & Mission
     * Membership & Observership
     * The European Pharmacopoeia Commission
     * Groups of Experts and Working Parties
     * European Pharmacopoeia 10th Edition
   * How to participate in the work of the Ph. Eur.
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     * Testing of falsified/illegal medicines within the GEON
     * Quality Monitoring of Stockpiled Medicines
     * Gene Therapy
   * Programmes EU/EEA Network
     * MRP/DCP Post Marketing Surveillance Scheme
     * CAP Sampling & Testing Programme
     * Human Biologicals (OCABR)
     * Veterinary Biologicals (OCABR/OBPR)
 * Transfusion & Transplantation
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Shipments of orders in December: check EDQM order reception deadlines
Products and Services News 10 November 2021 Strasbourg, France
To check whether orders for publications or reference standards can be shipped
in 2021, users are invited to consult the EDQM order reception deadlines for
December.
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PDG signs-off on milestone harmonised general chapter on chromatography
European Pharmacopoeia / International harmonisation News 08 November 2021
Strasbourg, France
The harmonised general chapter Chromatography was signed-off by the
Pharmacopoeial Discussion Group (PDG), which brings together the European
Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States
Pharmacopeia (USP), on 28 September 2021. The coordinating...
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EDQM closure Thursday 11 and Friday 12 November 2021
News 08 November 2021 Strasbourg, France
Due to public holidays in France, the European Directorate for the Quality of
Medicines & HealthCare (EDQM) will be closed on Thursday 11 and Friday 12
November 2021.
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MORE NEWS

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5 new Ph. Eur. reference standards and 19 replacement batches...
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
announces the availability of 5 new European Pharmacopoeia (Ph. Eur.) reference
standards and 19 replacement batches for Ph. Eur. reference standards,...
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Vacancy: Distribution Operator
Are you rigorous and work-orientated? Do you have a technical qualification in
logistics and professional experience relevant to the profile? Do you wish to
acquire valuable experience in the distribution of pharmaceutical reference...
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Vacancy - Scientific Assistants
Would you like to build a career in regulatory affairs? Do you have excellent
chemical synthesis or analytical chemistry skills? Do you have the scientific
expertise required to check the acceptability of applications for...
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AGENDA

14 December 2021
Strasbourg, France
Particulate contamination in parenteral preparations: wha...

See all events

See Reference standards Catalogue
Ph. Eur. 10th Edition presentation
Reference Standards & publication store
Free Publications and Databases
Certification of Suitability (CEP) News
Have a question? FAQ & HelpDesk
https://www.edqm.eu/en/edqms-response-nitrosamine-contamination

Nitrosamine contamination
In brief
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Since N-nitrosamines, possible carcinogens for humans, were detected in 2018 in
a number of active substances, the EDQM has been working with regulatory
authorities to ensure that no medicinal products containing nitrosamine
contaminants reach the end user. This has involved, among others, reviewing
Certificates of suitability (used in marketing authorisation applications),
revising European Pharmacopoeia monographs for the active substances concerned
and establishing new reference standards to support the implementation of the
new Ph. Eur. general chapter on the analysis of N-nitrosamines. The EDQM OMCL
Network has also co-ordinated the development of testing procedures that ensure
adequate control of impurities and a risk-based sampling and testing programme.

https://www.edqm.eu/en/news/all

The Vision of the EDQM
In brief
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 * A Directorate of the Council of Europe created in 1964.
 * A leading organisation that protects public health by enabling the
   development, supporting the implementation and monitoring the application of
   quality standards for safe medicines and their safe use.
 * Also develops guidance and standards in the areas of blood transfusion, organ
   transplantation and consumer health issues.

https://www.edqm.eu/en/news/european-pharmacopoeia

The European Pharmacopoeia
In brief
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 * Main objective is to provide common quality standards to control the quality
   of medicines and of substances used in the manufacture of medicines (human
   and veterinary use).
 * Legally binding in European member states.
 * 39 signatory parties (including the EU) and 30 observers (including WHO and
   TFDA) as of March 2018.

https://www.edqm.eu/en/news/omcl-network

Official Medicines Control Laboratories (OMCL)
In brief
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 * A network of independent public laboratories appointed by the national
   authorities.

 * Around 70 laboratories provide human and technical resources to implement
   testing programmes.

 * 36 European countries and 5 countries outside Europe participate in the
   various activities and programmes.

https://www.edqm.eu/en/news/certification-of-suitability

The Certification of Suitability
In brief
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 * Established in 1994.
 * Over 4,900 certificates covering more than 1,100 substances have been granted
   in more than 60 countries.
 * Assessment is jointly performed by a network of around 100 assessors from the
   national competent authorities and EDQM assessors.
 * Organises an inspection programme involving a network of around 30 inspectors
   from 20 different national competent authorities and the EDQM.

 

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COVID-19 pandemic
Focus
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The EDQM’s core activities include the provision of documentary and physical
(reference) standards to ensure the quality of medicines and their ingredients.
Availability of and access for patients to quality medicines is more important
than ever in the context of the current COVID-19 pandemic. This is why the EDQM
is working hard to ensure the continuous supply of our goods and services and is
engaging with all stakeholders, including national, European and international
authorities, to help protect public health.

 * The EDQM’s contributions to the protection of public health in the COVID-19
   pandemic: latest information
 * EDQM business continuity plan to safeguard core activities
 * EDQM initiatives in the context of COVID-19 vaccines and therapies

 

 


LATEST PRODUCTS AND SERVICES

10 November 2021
Shipments of orders in December: check EDQM order reception deadlines
05 August 2021
6 new reference standards and 16 replacement batches released in July...
05 July 2021
Pharmeuropa 33.3 just released
See all Products and Services news


HOW TO ORDER

Via our web store at store.edqm.eu in order to benefit from free handling
charges (on publications only). Alternatively, you can send your order to the
EDQM Sales section by:

 * post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg,
   France
 * e-mail: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.


@EDQM_NEWS ON TWITTER




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