Tower Mains Weekly Newsletter
Tower Mains will be hosting a webinar on the 18th of May 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.
ICH issues dates for virtual conferences to discuss revisions to the E6 on GCP revision
The International Council for Harmonisation (ICH) will hold a virtual conference on the 18th-19th May 2021 to discuss revision 3 of the E6 guideline on Good Clinical Practice (GCP).
MHRA response to JCVI advice on COVID-19 Vaccine AstraZeneca for people aged under 40
On 7th May 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement from Dr June Raine, MHRA Chief Executive, in response to the Joint Committee on Vaccination and Immunisation’s (JVCI) new advice on COVID-19 Vaccine AstraZeneca for people under 40. The statement confirmed the MHRA’s position that the benefits of the COVID-19 Vaccine AstraZeneca against COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks for most people. The MHRA updated its guidance with a link to the response.
MHRA issues its first authorisation under Project Orbis
Osimertinib (Tagrisso), a medicine made by AstraZeneca, will be the first to receive an authorisation from the MHRA under Project Orbis – only four months after the agency joined the scheme in January 2021. Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland, Singapore, Brazil, and the UK as other participants. The programme was set up to allow participating partners to review and approve applications for promising cancer treatments quickly and efficiently.
ICMRA and WHO call for wider public access to clinical data
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organisation (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity, and can stimulate research and development, which could have a positive impact on vaccine confidence.
EMA issues highlights from its PRAC meeting held on the 3rd– 6th May
On 7th May 2021, the EMA issued highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) on the 3rd-6th of May 2021. Highlights include the conclusion of the review of the signal of facial swelling with COVID-19 vaccine Comirnaty, and the analysis data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome (GBS) reported following vaccination.
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
On 7th May 2021, the EMA announced that its human medicines committee (CHMP) had started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, Inc. for the treatment of COVID-19. The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to prevent hospitalisation or death in non-hospitalised patients with COVID-19.
EC launches public consultation on the revision of the legislation on medicines for children and rare disease
On 10th May 2021, the European Commission (EC) launched an open public consultation on the revision of the legislation on medicines for children and rare disease (medicines for special populations). This is an important step in the process of assessing the impact of possible amendments to EU rules for these medical areas which builds on the recent evaluation published in summer 2020.
MHRA Inspectorate Blog: Is your eSystem actually an eCRF (electronic case report form)?
On 11th May 2021, the MHRA published a blog on eSystems. The MHRA Good Clinical Practice (GCP) inspectorate has noticed that some eSystems do not have the same functional requirements for an eCRF to meet International Council for Harmonisation (ICH) GCP expectations and ensure data integrity.
EMA announce additional measures to allow experts to focus on COVID-19 activities
On 11th May 2021, the EMA announced it was EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network to enable experts to deal with an increasing volume of COVID-19-related assessment procedures.
Issue Number: WN00010