Tower Mains Weekly Newsletter

Regulatory Updates

Eudralex Volume 4 Annex 21 Importation of medicinal products published

16 February 2022 The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 21: Importation of medicinal products has been officially published. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use, and Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and Commission Delegated Regulation (EU) 2017/1569 supplementing it. Deadline for coming into operation: 21 August 2022 (6 months after publication).

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Industry Updates

EMA issues meeting highlights from February PRAC meeting

On 11th February, the European Medicines Agency issued meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 7th-11th of February 2022. Highlights include the recommendation of suspending hydroxyethyl-starch solutions for infusion from the market and the safety review of Janus kinase inhibitors for inflammatory disorders.

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MHRA publishes Part 2 of blog on the conduct of Clinical Trials during the pandemic

On the 14th of February 2022 the GCP inspectorate published the second blog in this series detailing the challenges they confronted in the  set up and conduct of trials during the pandemic. Also discussed are their lessons learned.

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MHRA publishes blog on the new standards applicable for investigational medicines applicable from Jan 31st

With the Clinical Trial regulation (CTR) coming into force in the European Union on Monday 31 January 2022 there have been implications regarding the manufacturing of investigational medicines. In that the revised Annex 13 is now effective (from 31 January 2022), however pending completion of the UK’s future clinical trial legislation, the UK will also continue to apply the January 2010 version of Annex 13

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FDA issues educational material for medical devices

The FDA’s Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) is providing resources with the most current and accurate information about medical devices and radiation-emitting electronic products. CDRH recently updated web pages in Device Advice and launched a new playlist on the FDA YouTube Channel CDRH Learn Video Playlist: Medical Device Education Basics 101.

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Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19

On the 11th of February 2022 the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients.

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BioNTech introduces modular mRNA manufacturing facilities for Africa

The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer. This allows for mRNA vaccine production in bulk (mRNA manufacturing and formulation), while fill-and-finish will be taken over by local partners. Together, two modules offer an estimated initial capacity of for example up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year. The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of Africa, for example the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines The capacity can be scaled up by adding further modules and sites to the manufacturing network on the African continent.

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Issue Number: WN00049

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