Tower Mains Weekly Newsletter

Industry Updates

WHO recommends the use of Regeneron and Roche’s COVID-19 antibody cocktail

​​On 24th September 2021, the World Health Organisation (WHO) panel announced a recommendation of the use of Regeneron and Roche’s COVID-19 antibody cocktail for patients at high risk of hospitalisation and those severely ill with no existing natural antibodies. In June, Britain’s RECOVERY trial found the therapy reduced deaths in hospitalised patients whose own immune systems had failed to produce a response. The treatment, a combination of casirivimab and imdevimab, is based on a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the human body to fight off infections.

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MHRA GLP Data Integrity Requirements Update

On 27th September 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated information regarding data integrity following publication of the OECD guidance document. The blog contains useful information about the differences between the previous MHRA guidance and the OECD document. It also states, “Members of the UK GLP Monitoring Programme should conduct a documented review of their existing data integrity processes against the OECD document to ensure that they fully comply and that any required changes or additions are implemented. This activity is likely to be reviewed at the next inspection of the facility.”

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MHRA updates information about the Pfizer/BioNTech vaccine

On 27th September 2021, the MHRA updated the information for healthcare professionals and the public about the Pfizer/BioNTech vaccine to include the recently extended vaccine shelf life from six months to nine months.

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FDA and UK announce mutual recognition agreement for pharmaceutical GMP inspections of animal drugs

On 27th September 2021, the U.S. Food and Drug Administration (FDA) and the United Kingdom’s Veterinary Medicines Directorate (VMD) announced their decision to expand the scope of the US-UK Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals.

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EMA evaluating data on booster dose of Spikevax COVID-19 vaccine

On 27th September 2021, the European Medicines Agency (EMA) announced it had started evaluating an application for the use of a booster dose of Spikevax COVID-19 vaccine to be given at least six months after the second dose in people aged 12 years and older. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Spikevax, including results from an ongoing clinical trial. Based on this review, the CHMP will recommend whether updates to the product information are appropriate. The EMA will communicate the outcome of the assessment in due course.

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European Commission publishes a public consultation on the revision of the EU’s pharmaceutical legislation

On 28th September 2021, the European Commission published a public consultation on the revision of the EU’s pharmaceutical legislation as part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector. This is the latest step towards an ambitious reform as announced in the Pharmaceutical Strategy for Europe, adopted in November 2020. The consultation will end on the 21st of December 2021.

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MHRA updates guidance on the submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing

On 28th September 2021, the MHRA updated its guidance on how Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present. Information was added about submission under section ‘Step 2 – Risk assessment and confirmatory testing’.

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MHRA updates its list of conferences and events

On 29th September 2021, the MHRA added its next public Board Meeting to its list of conferences and events. The next meeting will be a webinar and will be held on the 19th of October 2021.

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EMA implements new measures to minimise animal testing during medicines development

On 29th September 2021, the EMA announced it is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The agency is promoting these three principles — replace, reduce, and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes. The ITF’s service is free of charge and any NAMs adhering to the 3Rs principles that can be used to fulfil testing requirements are eligible for consideration.

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Issue Number: WN00030

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