Tower Mains Weekly Newsletter
We are delighted to welcome Nicole LeBlanc as QA Associate. Nicole will be conducting audits of GxP labs on behalf of clients and supporting clients in quality activities.
MHRA publishes time-based performance measures for October
On 5th November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated statistics on the expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.
FDA authorises iHealth COVID-19 Antigen Rapid Test
On 5th November 2021, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022.
EMA publishes highlights from the latest CVMP meeting
On 8th November 2021, the European Medicines Agency (EMA) published meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) on the 3rd-4th November 2021.
EMA and HMA agree to review available date on molnupiravir
On 9th November 2021, the EMA and the Heads of Medicines Agencies (HMA) announced they had agreed on the need for additional guidance on COVID-19 treatments considering rising rates of infection and deaths due to COVID-19 across the EU. To this end, EMA is reviewing available data on the use of molnupiravir to support national authorities who may decide on the use of this medicine for COVID-19 treatment prior to its authorisation.
International organisations and manufacturers take stock of vaccine roll-out and discuss outlook for 2022
On 10th November 2021, the World Health Organisation (WHO) issued a joint statement of the Multilateral Leaders Task Force on Scaling COVID-19 tools. This follows a meeting on the 9th of November where international organisations met with the CEOs of leading COVID-19 vaccine manufacturing companies. The objective of the meeting was to identify how to ensure more equitable distribution of vaccines and all those participating pledged to continue working together to gain greater clarity on donations, vaccine swaps, and delivery schedules so that distribution of the life-saving vaccines can be more effectively targeted towards those countries most in need. The outlook for 2022 was also discussed, focusing on diversification of manufacturing across regions, as well as strengthening collaboration to achieve the global target of vaccinating 70% of the populations of all countries by the middle of the year.
EMA starts evaluating use of Spikevax COVID-19 vaccine in children aged 6 to 11
On 10th November 2021, the EMA announced it had started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11. EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 6 to 11, to decide whether to recommend extending its use. The current timeline for evaluation foresees an opinion in approximately two months unless supplementary information or analysis is needed.
European Commission issues documents from 96th Pharmaceutical Committee meeting
On 10th November 2021, the European Commission issues documents from 96th Pharmaceutical Committee held on the 17th September.
Issue Number: WN00036