Past News
Transplantation / Publications / Transplant Newsletter |
News |
10 October 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.
European Pharmacopoeia / International harmonisation |
News |
08 October 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 increasing the availability of medicines. Representatives of the three PDG members (the European...
Products and Services |
News |
03 October 2019 |
Strasbourg, France
The EDQM announces the availability of 15 New Ph. Eur. reference standards and 16 Replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) |
Notes |
30 September 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 communicated 5 weeks after the expected date). EDQM does assure applicants that the outcome will be...
Transplantation / Publications |
News |
20 September 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 and safety of human tissues and cells for human application.
Certification of suitability (CEP) |
News |
16 September 2019 |
Strasbourg, France
The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers.
European Pharmacopoeia / General |
News |
05 September 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.
Products and Services |
News |
05 September 2019 |
Strasbourg, France
The EDQM announces the availability of:
• 2 New Ph. Eur. reference standards,
• 18 Replacement batches for Ph. Eur. reference standards.
European Pharmacopoeia / Monograph |
News |
03 September 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!
Transplantation / European Organ Donation Day (EODD) |
News |
30 August 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.
Products and Services |
News |
06 August 2019 |
Strasbourg, France
The EDQM announces the availability of:
• 11 new Ph. Eur. reference standards
• 28 replacement batches for Ph. Eur. reference standards
Information on reference standards removed from catalogue.
Information on change of sales units.
Information on changes of storage / shipping conditions.
Information on reference standards currently out of stock.
The Ph. Eur. Reference Standards...
Certification of suitability (CEP) / Procedure of certification (general) |
News |
17 July 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.
European Pharmacopoeia / General text/chapter |
News |
15 July 2019 |
Strasbourg, France
At its 162nd session in November 2018, the Ph. Eur. Commission adopted a new version of one of its major general methods. Ultraviolet and visible absorption spectrophotometry (2.2.25) has undergone extensive revision and is published in the 10th Edition (implementation date 1 January 2020).
Certification of suitability (CEP) / Procedure of certification (general) |
News |
15 July 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. Therefore, all such submissions need to be in eCTD format.
European Pharmacopoeia / Public enquiry |
News |
15 July 2019 |
Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving intravesical preparations. These proposed revisions have been published in Pharmeuropa 31.3 and concern the following texts...