EDQM - European Directorate for the Quality of Medicines |

Time 2020-11-10 16:04:44

Web Name: EDQM - European Directorate for the Quality of Medicines |

WebSite: http://www.edqm.eu

ID:111357

Keywords:

Directorate,for,EDQM,

Description:

8 new reference standards and 24 replacement batches released in October 2020 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. CEP holders invited to comment on draft monographs published in Pharmeuropa 32.4 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. The table below lists the substances affected by these revisions and for which CEPs have been granted. New EDQM document on recombinant viral vectored vaccines to support COVID-19 vaccine developers EDQM / 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,... Launch of public consultation on the CEP of the future 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. EDQM office closure The EDQM will be closed on Wednesday 11 November 2020. New Council of Europe resolution to strengthen safety of food contact... 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... In 2018, certain types of nitrosamines (N‑nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA)) were detected in a number of active substances used in the treatment of hypertension and in related medicines. Nitrosamines are known as possible carcinogens for humans: only very low amounts are acceptable according to current regulatory requirements (ICH M7 “cohort of concern”). Their detection requires highly sensitive analytical methods. As clarified by the European Medicines Agency (EMA), their presence in active substances may be linked to several factors, e.g. from processing conditions to accidental introduction due to cross-contamination (from processes running in parallel on the same production lines) or recovery procedures for solvents, or also from degradation of the substances.A Directorate of the Council of Europe created in 1964.A leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.Main objective is to provide common quality standards to control the quality of medicines and of substances used in the manufacture of medicines (human and veterinary use).Legally binding in European member states.39 signatory parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018. https://www.edqm.eu/en/news/omcl-network Official Medicines Control Laboratories (OMCL) In brief twitterfacebookgooglepluspinterestlinkedinemailAround 70 laboratories provide human and technical resources to implement testing programmes.36 European countries and 5 countries outside Europe participate in the various activities and programmes.Established in 1994.Over 4,900 certificates covering more than 1,100 substances have been granted in more than 60 countries.Assessment is jointly performed by a network of around 100 assessors from the national competent authorities and EDQM assessors.Organises an inspection programme involving a network of around 30 inspectors from 20 different national competent authorities and the EDQM. The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic. This is why the EDQM is working hard to ensure the continuous supply of our goods and services and is engaging with all stakeholders, including national, European and international authorities, to help protect public health.EDQM business continuity plan to safeguard core activities Via our web store at store.edqm.eu in order to benefit from free handling charges (on publications only). Alternatively, you can send your order to the EDQM Sales section by:post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg, Francee-mail: orders@edqm.eu Invoices can be paid by credit card via internet or by bank transfer. EDQM Council of Europe, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France, Tel. +33 3 88 41 30 30 / Fax +33 3 88 41 27 71

TAGS:Directorate for EDQM 

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