Tower Mains Weekly Newsletter
On the 18th of May, Tower Mains will be hosting a webinar on the benefits of having a quality management system (QMS) and why you need one. To learn the benefits of having one in your organisation, book your place here.
EMA evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
On 29th April 2021, the European Medicines Agency (EMA) announced it had started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10 years old who require supplemental oxygen.
ICH collaborates with SNOMED International to promote seamless data exchange
On 29th April 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced it had collaborated with SNOMED International to release new maps between global medical terminologies SNOMED CT and MedDRA. The joint effort has produced two independent maps derived from frequently used and key pharmacovigilance MedDRA terms identified from the EMA and the Medicines and Healthcare products Regulatory Agency (MHRA). In addition, a set of COVID-19 related terms are also included in the first production release of the maps to capture important aspects of the pandemic.
Moderna announces Emergency Use Listing (EUL) for its COVID-19 vaccine by the World Health Organisation
On 30th April 2021, Moderna, Inc. announced that the World Health Organization (WHO) had issued an Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. The EUL process assesses novel health products during public health emergencies with the goal of making medicines, vaccines and/or diagnostics available to address the emergency while adhering to stringent criteria of safety, efficacy, and quality.
EMA evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
On 3rd May 2021, the EMA announced it had started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty – currently authorised for use in people aged 16 or over – to include young people aged 12 to 15. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted, including results from a large ongoing clinical study involving adolescents from 12 years of age, to decide whether to recommend the extension of indication.
Moderna announces supply agreement with Gavi for up to 500 Million Doses of COVID-19 Vaccine for COVAX
On 3rd May 2021, Moderna, Inc. announced an agreement with Gavi, the Vaccine Alliance, to supply up to 500 million doses of its COVID-19 vaccine. This agreement covers the 92 Gavi COVAX Advance Market Commitment (AMC) low- and middle-income countries.
MHRA appoints Dr Alison Cave as new Chief Safety Officer
On 4th May 2021, the MHRA announced the appointment of Dr Alison Cave as its new Chief Safety Officer. As a member of the Executive Committee, Alison will lead on safety and vigilance functions and become a Board Director of the Agency.
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
On 4th May 2021, the EMA announced its human medicines committee (CHMP) had started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. EMA will evaluate data as is becomes available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
FDA issues report outlining inspectional activities during COVID-19 pandemic
On 5th May 2021, the FDA issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.
Issue Number: WN0009