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European Pharmacopoeia / General text/chapter | News | 23 May 2018 | Strasbourg, France
Following up on issues that were reported with the revised limit test on Arsenic (method A, 2.4.2) published in Supplement 9.4., the Ph. Eur. Commission decided to revert back to the previous version of the chapter 2.4.2., until further notice.
Certification of suitability (CEP) | News | 22 May 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).
European Pharmacopoeia / Pharmacopoeial discussion group (PDG) | News | 15 May 2018 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), consisting of representatives from the European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), the United States Pharmacopoeia (USP) and the WHO (International Pharmacopoeia) as observer, held its first interim videoconference on Wednesday 11 April 2018.
European Pharmacopoeia | News | 15 May 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.
European Pharmacopoeia / 3Rs | News | 11 May 2018 | Strasbourg, France
An article summarising the activities of the European Pharmacopoeia Commission in the field of the 3Rs within the last decade has just been published. In addition to the progress in the Ph. Eur. texts, the article also describes tools utilised in the implementation of the 3R principles as well as the challenges encountered and future perspectives.
Products and Services | News | 11 May 2018 | Strasbourg, France
5 new Ph. Eur. Reference Standards (RS) were released in April 2018
Transplantation / Donation Campaigns & European Organ Donation Day (EODD) | News | 09 May 2018 | Strasbourg, France
To improve the situation and change the perception of donation and transplantation continent-wide, the EDQM is launching a communication campaign on its social media, which will run throughout the summer until the European Organ Donation Day (EODD) celebration in October.
Certification of suitability (CEP) / Inspection | News | 24 April 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.
Transplantation / Organ | News | 23 April 2018 | Strasbourg, France
The Committee on Organ Transplantation (CD-P-TO) has issued a recommendation not to engage in Global Kidney Exchange (GKE) programmes and to support instead the development of fair and equitable kidney paired exchange programmes.
European Pharmacopoeia / Ph. Eur. Commission | News | 17 April 2018 | Strasbourg, France
The Ph. Eur. Commission decided at its 160th session of March 2018 to reactivate its dedicated GTP Working Party. Experts from both Ph. Eur. and non Ph. Eur. member states are welcome to participate in this work.
Products and Services | News | 17 April 2018 | Strasbourg, France
The 2019 subscriptions are now available for sale on our webstore. Don’t delay, order your subscription now!
European Pharmacopoeia / Ph. Eur. Commission | News | 16 April 2018 | Strasbourg, France
The European Pharmacopoeia Commission achieved an important milestone on quality requirements for Live Biotherapeutic Products (LBPs) for human use with the adoption of quality standards.
European Pharmacopoeia / General text/chapter | News | 13 April 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission launches a public consultation on its proposal to replace the Histamine Sensitisation Test (HIST) for residual pertussis toxin testing.
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 09 April 2018 | Strasbourg, France
OCABR guidelines for vaccines with acellular Pertussis (aP) components have been revised to remove an animal test used for OCABR.
European network of OMCLs / General European OMCLs Network activities | News | 09 April 2018 | Strasbourg, France
GEON quality management document: The guideline “Validation of Computerised Systems” has been revised