New OCABR guideline on inactivated COVID-19 vaccines

EDQM 04/05/2022 Strasbourg, France

The new Official Control Authority Batch Release (OCABR) “Guideline for Pandemic COVID-19 Vaccine, Inactivated”, containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 4 May 2022. The availability of...

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Full OCABR Guideline for Pandemic COVID-19 vaccine (Recombinant Spike Protein) now available

EDQM 08/03/2022 Strasbourg, France

The Pandemic COVID-19 vaccine (Recombinant Spike Protein) guideline, in force since 30 November 2021, contains the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR). It has been updated to include a model...

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EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers

EDQM 02/07/2021 Strasbourg, France

Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a...

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IMWP monographs on Favipiravir and on Favipiravir tablets published for public enquiry

EDQM 03/05/2021 Strasbourg, France

The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health...

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New OCABR guidelines on COVID-19 recombinant spike protein vaccines and non-replicating adenovirus-vectored COVID-19 vaccines

EDQM 23/04/2021 Strasbourg, France

The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021. The...

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Full OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available

EDQM 07/04/2021 Strasbourg, France

The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. This key guideline has been in force since 12 November 2020 with the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for...

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COVID-19 and vaccines: Equitable access to vaccination must be ensured

EDQM 22/01/2021 Strasbourg, France

How can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of recommendations. First, strategies should be put in place to avoid generating discrimination due to material aspects, such as...

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EDQM releases updated European Pharmacopoeia vaccines package for COVID-19 vaccine developers

EDQM 23/11/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines. Originally published in June 2020, the package now includes a further 17 texts on analytical methods which are referenced in the recently...

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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

EDQM 12/11/2020 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...

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New EDQM document on recombinant viral vectored vaccines to support COVID-19 vaccine developers

EDQM 03/11/2020 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...

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Ensuring the availability of quality standards for medicines in the context of the COVID-19 pandemic

EDQM 30/10/2020 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...

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Products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of COVID-19

EDQM 16/10/2020 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...

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EDQM continues to support COVID-19 vaccine developers by providing selected training materials

EDQM 11/06/2020 Strasbourg, France

Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts (see “ EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe”), the EDQM has compiled a companion list of training materials on the European Pharmacopoeia...

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Impact of COVID-19 crisis – National authorities in Europe report shortages of medical products and increase in illegal activities

EDQM 09/06/2020 Strasbourg, France

The Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) held its spring meeting via videoconference from 26 to 28 May 2020. Some 35 delegates from 24 countries participated. A dedicated discussion took place to...

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EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe

EDQM 08/06/2020 Strasbourg, France

The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards. The EDQM and the...

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Annual OMCL Network meeting focuses on role of OMCLs during the COVID-19 pandemic

EDQM 28/05/2020 Strasbourg, France

The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the EDQM. The...

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EDQM webinar: tissue donation from deceased donors during the COVID-19 pandemic

EDQM 30/04/2020 Strasbourg, France

Maintaining a safe, sufficient and accessible supply of critical and essential tissues for human application during a pandemic is of vital importance to public health systems that support donation and transplantation. With this in mind, the EDQM organised a webinar for the tissue donation and...

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FREE Webinar Tissue donation from deceased donors during the COVID-19 pandemic 28 April 2020

EDQM 20/04/2020 Strasbourg, France

Webinar : Tissue donation from deceased donors during the COVID-19 pandemic, 28 April 2020, 3 pm – 5.30 pm (CEST) The European Directorate for the Quality of Medicines & HealthCare is pleased to invite you to a webinar to discuss how the COVID-19 pandemic is affecting national programmes for...

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Prioritisation of activities related to CEPs during COVID-19 contingency measures period

EDQM 14/04/2020 Strasbourg, France

In the context of having switched to working remotely during the COVID-19 pandemic, the EDQM has prioritised certain activities linked with CEPs over others and it is important to share this with our stakeholders. Priority is being given to activities related to assessment of all kinds of CEP...

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COVID-19 – How to contact the EDQM

EDQM 19/03/2020 Strasbourg, France

Due to the measures implemented by the French government in its fight against the COVID-19 pandemic, the EDQM will, until further notice, only be able to answer queries through its Online HelpDesk. We will continue to do our utmost to provide you with the best possible service, but please note...

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