Covid-19 | News | 23 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines.
Products and Services | News | 18 November 2020 | Strasbourg, France
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the EDQM offices from 23 December 2020 (12 noon CET) to 4 January 2021 (8 a.m. CET).
Certification of suitability (CEP) / Procedure of certification (general) | News | 13 November 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Covid-19 | News | 12 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are...
Certification of suitability (CEP) / Procedure of certification (general) | News | 09 November 2020 | Strasbourg, France
The EDQM is launching a project to design the CEP of the future. The consultation will remain open until 31 December 2020 in the form of an online survey.
Reference Standard / Collection & Catalogue | News | 09 November 2020 | Strasbourg, France
The EDQM announces the availability of: 8 new European Pharmacopoeia (Ph. Eur.) reference standards and 24 replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) | News | 05 November 2020 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 32.4.
Covid-19 | News | 03 November 2020 | Strasbourg, France
A broad range of technologies are being evaluated in the development of COVID-19 vaccines, from conventional approaches, such as live attenuated and inactivated vaccines, to more recent technologies, such as nucleic acid vaccines and recombinant viral vectored vaccines. Currently, limited guidance is available covering the quality of such new technologies.
Reference Standard / Collection & Catalogue | News | 30 October 2020 | Strasbourg, France
In the context of the COVID-19 pandemic, the availability of quality medicines is more important than ever. Unfortunately, since the start of the sanitary crisis, shortages of medicines have increased around the world, and notably of those to treat or alleviate COVID-19 symptoms or used in intensive care units (ICUs). In addition, a number of clinical trials are under way around the world, using...
Transplantation / Legal Framework | News | 27 October 2020 | Strasbourg, France
On 21 October 2020, Switzerland ratified the Council of Europe Convention against Trafficking in Human Organs, also known as the Santiago de Compostela Convention. The convention will enter into force in the country as of 1 February 2021. This legal instrument identifies various activities constituting human organ trafficking that ratifying member states must consider as criminal offences. By...
Patient & Consumer Protection / Food contact material | News | 19 October 2020 | Strasbourg, France
The Committee of Ministers of the Council of Europe has adopted a new resolution on the safety and quality of materials and articles for contact with food. This instrument is expected to improve the protection of consumers from contaminants (metals, antioxidants, stabilisers, colorants, plasticisers, etc.) potentially released by material in contact with food, such as containers, work surfaces or...
Paediatric Formulary | News | 16 October 2020 | Strasbourg, France
During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication are currently ongoing and medicinal products are also being used experimentally in clinical practice. Reference is made to the WHO information on “Clinical management of severe acute respiratory infection (SARI) when COVID-19...
European Pharmacopoeia / International harmonisation | News | 14 October 2020 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020, with WHO attending as observer. Due to the COVID-19 pandemic, the face-to-face meeting originally scheduled was reorganised as a videoconference devoted entirely to...
Transplantation / European Organ Donation Day (EODD) | News | 08 October 2020 | Strasbourg, France
Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the quality of life of patients, for example, by restoring their sight. On average, 41 000 organ...
Transplantation / Legal Framework | News | 08 October 2020 | Strasbourg, France
The Committee of Ministers of the Council of Europe has adopted two new recommendations, calling on member states to ensure that quality and safety standards for the donation and transplantation or human application of organs, tissues and cells are respected in accordance with the technical guides published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the...