EDQM - European Directorate for the Quality of Medicines

European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable version available to order

Products and Services News 23 May 2017 Strasbourg, France

Supplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018

Ph. Eur. seeks feedback on alternatives to DEHP for blood bags

European Pharmacopoeia / General News 16 May 2017 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has launched a public consultation on its proposal to include in its texts 4 plasticisers that can be added to PVC (poly(vinyl chloride)) for manufacturing blood containers and sets for blood transfusions.

NEW: The 19th edition of the Blood Guide is now available

Products and Services News 04 May 2017 Strasbourg, France

This 19th Edition of the Guide to the preparation, use and quality assurance of blood components was elaborated by a dedicated ad hoc working group of experts nominated by the European Committee (Partial Agreement) on Blood Transfusion.

Previous Pause Next

More news

Certification Monthly Report of Activities: April 2017

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

Pharmeuropa: Issue 29.2 is complete. Comments before 30 June 2017

Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.

Update of application forms “Request for new CEP” and “Request for...

The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised...

Agenda

17 June 2017 to 21 June 2017

Copenhagen, Denmark

27th Regional Congress of the ISBT

20 June 2017 to 22 June 2017

Shanghai, China

CPhI China

11 July 2017 to 12 July 2017

Strasbourg, France

European Pharmacopoeia Training

See Reference standards Catalogue

Ph. Eur. 9th Edition presentation

Reference Standards & publication store

Access free Databases

Certification of Suitability (CEP) News

Have a question? FAQ & HelpDesk

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

The Vision of the EDQM

In brief

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

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.
38 signatory parties (including the EU) and 29 observers (including WHO and TFDA) as of November 2016.

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

Official Medicines Control Laboratories (OMCL)

In brief

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

Established in 1994.
Over 4,200 certificates covering more than 1,000 substances have been granted in more than 50 countries.
Assessment is jointly performed by assessors from the national competent authorities and EDQM assessors
Organises an inspection programme involving a network of around 100 assessors and 30 inspectors from 24 different national competent authorities and the EDQM.

https://www.edqm.eu/en/news/transfusion-and-transplantation

HealthCare Activities

In brief

Blood Transfusion & Organ Transplantation: elaborating ethical, legal and safety standards.
Pharmaceutical Care : developing and promoting best practices
Anti-counterfeiting activities: supporting the protection of public health.
Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.

Previous Pause Next

https://www.edqm.eu/en/en/membership-observership

Ph. Eur.: Republic of Moldova becomes 39th Member

Focus

On 24 January 2017, the Permanent Representation of the Republic of Moldova to the Council of Europe handed to Mr Thorbjørn Jagland, Secretary General of the Council of Europe, the instrument of accession to the Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989.
The Convention has entered into force in the Republic of Moldova on 25 April 2017, making the country the 39th Member State of the European Pharmacopoeia.

More information on Ph. Eur. Members and observers.

Latest products and services

23 May 2017

European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable...

04 May 2017

NEW: The 19th edition of the Blood Guide is now available

03 April 2017

Pharmeuropa: Issue 29.2 is complete. Comments before 30 June 2017

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
email: orders@edqm.eu

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

@Edqm_news on Twitter

Tweets by edqm_news

Videos

https://www.edqm.eu/en/../en/presentation-edqm

https://www.edqm.eu/en/../en/9th-edition-european-pharmacopoeia-maintaining-high...

https://www.edqm.eu/en/../en/inside-the-council-of-europe