EDQM | News | 12 June 2018 | Metz, France
The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main building in Strasbourg.
Products and Services | News | 07 June 2018 | Strasbourg, France
3 new Ph. Eur. Reference Standards (RS) were released in May 2018
European Pharmacopoeia / Monograph | News | 05 June 2018 | Strasbourg, France
The monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur.
European network of OMCLs / General European OMCLs Network activities | News | 25 May 2018 | Strasbourg, France
The Annual Meeting of the Official Medicines Control Laboratories (OMCLs) took place on 14-18 May in Sarajevo (Bosnia and Herzegovina). It was attended by 230 participants from 38 countries, representing 65 official laboratories and including a representative of the OMCL Network, the Taiwan Food and Drug Administration, which just joined the Network as an associated member.
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.
Pharmaceutical care / Classification of medicines | News | 23 May 2018 | Strasbourg, France
The Committee of Ministers adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them...
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 | 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 / 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.
Products and Services | News | 11 May 2018 | Strasbourg, France
5 new Ph. Eur. Reference Standards (RS) were released in April 2018
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.
Transplantation / 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.
Products and Services | News | 17 April 2018 | Strasbourg, France
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