Tower Mains Weekly Newsletter
MHRA to play a greater role in setting global standards for medicines and medical devices regulation
On 16th June, the Medicines and Healthcare products Regulatory Agency (MHRA) was accepted as a full member of three international work-sharing partnerships – the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. Through these partnerships, the MHRA will share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.
Moderna and Pfizer-BioNTech vaccines authorised for use in children down to 6 months of age in the US
On 17th June, the US Food and Drug Administration (FDA) authorised emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age:
- For the Moderna vaccine, the FDA amended the emergency use authorisation (EUA) to include the use of the vaccine in individuals aged six months through 17 years of age. The vaccine had been authorised for use in adults 18 years of age and older.
- For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include the use of the vaccine in individuals aged six months through four years of age. The vaccine had been authorised for use in individuals five years of age and older.
Global regulators reflect on successful international collaboration and observational research during COVID-19 pandemic
On 17th June, the International Coalition of Medicines Regulatory Authorities (ICMRA) issued minutes from the 7th on COVID-19 Real-World Evidence and Observational studies. Chaired by Xavier Kurz (European Medicines Agency – EMA) and Kelly Robinson (Health Canada – HC), the meeting aimed to illustrate successful collaboration to date through updates from the three technical ICMRA working groups, discuss key lessons learned over the last two years, and to brainstorm on what the future holds beyond the COVID-19 pandemic.
EMA starts rolling review for adapted Spikevax COVID-19 vaccine
On 17th June, the EMA announced it has started a rolling review for a version of Spikevax adapted to provide better protection against two strains of SARS-CoV-2 – the original strain and the Omicron variant. The review will initially focus on data from laboratory studies and data on chemistry, manufacturing, and controls (CMC), which relate to the manufacturing of the vaccine. As the company makes progress in the development of its vaccine, the EMA will receive more data, including data on the immune response against the original strain and the Omicron variant of concern. The review will continue until there is enough data for a formal application.
ICMRA issues statement on the establishment of a pharmaceutical quality knowledge management system
On 17th June, ICMRA issued a joint statement on the establishment of a pharmaceutical quality knowledge management system (PQKMS), which could help to better inform both public and industry stakeholders on the coalition’s efforts to improve global regulatory harmonisation and alignment. Regulatory authorities can gain efficiencies by developing collective procedures, guidelines, requirements, and an interoperable infrastructure that would facilitate the sharing of information on changes occurring within the supply chain of medicines.
MHRA updates submission dates for its early access to medicines scheme
On 20th June, the MHRA updated the submission dates for its early access to medicines scheme (EAMS). The scheme aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
European Commission publishes summary record for the latest pharmaceutical committee
On 20th June, the European Commission published the summary record for the 99th meeting of the Pharmaceutical Committee, held on the 11th of May 2022. The meeting was organised via video conference and was attended by representatives from the Commission, 24 EU Member States, the EMA, and members of the Heads of Medicines Agencies Coordination Group for Mutual Recognition and decentralised procedures – human (CMDh). Topics include pharmaceutical legislation, pharmacovigilance and additional inspection capacity and building inspector capability and expertise to strengthen Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) compliance oversight within the EU/EEA.
MHRA updates submission dates for high-quality marketing authorisation applications
On 20th June, the MHRA updated the submission deadlines for 150-days assessment procedure for high-quality marketing authorisation applications (MAAs). For applications containing new active substances, submissions should be received by the updated submission dates to align with the meeting dates of the Commission on Human Medicines (CHM).
MHRA issues new advice on monitoring reduced vitamin B12 levels during metformin treatment
On 20th June, the MHRA issued new advice on monitoring reduced vitamin B12 levels during metformin treatment. Decreased vitamin B12 levels are now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those with existing risk factors. The MHRA advises checking vitamin B12 serum levels in patients being treated with metformin who have symptoms suggestive of vitamin B12 deficiency and advises that periodic monitoring for patients with risk factors for vitamin B12 deficiency should be considered.
MHRA publishes June’s Drug Safety Update newsletter
On 20th June, the MHRA issued the June edition of its Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines.
Issue Number: WN00066
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