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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.
EDQM's response to 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 / Legal Framework | News | 08 October 2020 | Strasbourg, France
The Committee of Ministers of the Council of Europe has adopted a recommendation calling on member states to take measures to protect the health of donors of haematopoietic progenitor cells (HPCs). These cells are used as a lifesaving treatment for patients with severe blood diseases and are the most frequently donated cells for transplantation.
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...
Reference Standard / Collection & Catalogue | News | 06 October 2020 | Strasbourg, France
The EDQM announces the availability of 10 new reference standards and 22 replacement batches, released in September 2020
Paediatric Formulary | News | 05 October 2020 | Strasbourg, France
The EDQM has just released issue 2 of Pharmeuropa PaedForm, in which the third monograph elaborated by the PaedForm Working Party, the draft text for an ethanol-free formulation for Furosemide 2 mg/mL Oral Solution, is published for public consultation prior to its inclusion in the European Paediatric Formulary.
European Pharmacopoeia / Monograph | News | 02 October 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.4 is now available and will be applicable in 39 European countries as of 1 April 2021.
European Pharmacopoeia / Public enquiry | News | 02 October 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.4 is 31 December 2020.
Transplantation / Public awareness | News | 02 October 2020 | Strasbourg, France
As health systems worldwide continue to cope with the impact of the COVID-19 pandemic, the EDQM/Council of Europe publishes this year’s issue of the Newsletter Transplant. The timely release of this issue is proof of the EDQM’s dedication to the international medical community and all those involved in the preparation of this publication.