Tower Mains Weekly Newsletter
MHRA publishes new Delivery Plan centred on putting patients first
On 4th July 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued its Delivery Plan 2021-2023, entitled ‘Putting patients first; A new era for our agency’. At its core, the plan details how the MHRA will draw together its scientific and regulatory expertise to help facilitate the UK life sciences sector and health service; develop new regulatory frameworks; quickly realise the benefits of new therapies and innovative technologies such as artificial intelligence (AI), to improve outcomes for patients; and ensure the continued safety, quality and efficacy of medicines and medical devices.
FDA issues final guidance on Unique Device Identifier
On 6th July 2021, the U.S. Food and Drug Administration (FDA) issued the final guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The guidance details the FDA’s recommendations for the form and content of the UDIs that must appear on devices according to the UDI Rule. It is intended to assist labellers and FDA-accredited issuing agencies in complying with UDI labelling requirements. This final guidance replaces the draft guidance of the same name issued on July 25, 2016.
MHRA and Health Canada publish guidance to improve patient safety in clinical trials
On 6th July 2021, the MHRA published guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports (DSURs). The guidance will improve transparency and ask sponsors to explain how they assessed the data included in the DSUR. The guidance builds on relevant existing international standards, including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance E2F. This joint publication reflects the UK effort to demonstrate how international collaboration contributes to international research, patient safety and global public health.
UK Life Sciences Vision sets 10-year strategy
On 6th July 2021, the government revealed its 10-year Life Sciences Vision which is set to solve some of the UK’s most significant health challenges including cancer, dementia, and obesity. The vision sets out seven critical healthcare missions that the government, industry, the NHS, academia, and medical research charities will work together on at speed. These missions include accelerating the pace of studies into novel dementia treatment, increasing the understanding of mental health conditions, and sustaining the UK’s position in vaccine discovery, development, and manufacturing.
MHRA updates information on granted EAMS scientific opinions
On 7th July, the MHRA updated its information on granted EAMS scientific opinions, including the public assessment report and treatment protocols. Risdiplam was removed from the list as the EAMS SO has expired.
COVID-19 Vaccine Updates
EMA announces increased manufacturing capacity for Janssen COVID-19 vaccine
On 2nd July 2021, the European Medicines Agency (EMA) announced that its committee for human medicines (CHMP) had approved a scale-up of the active substance manufacturing process at Janssen Biologics B.V. The approved modifications include a newly constructed building, new equipment, and the introduction of additional process optimisations. The site is expected to support the continued supply of the Janssen COVID-19 vaccine in the EU.
MHRA revises COVID-19 vaccine information for healthcare professionals and UK vaccine recipients
On 7th July, the MHRA revised the Moderna and Pfizer/BioNTech COVID-19 vaccine information for healthcare professionals and vaccine recipients following a thorough review of suspected adverse reaction reports of myocarditis and pericarditis in vaccine recipients. The Commission on Human Medicines (CHM) reviewed the available data and advised that healthcare professionals should be alert to the signs and symptoms in vaccinated individuals, and vaccinated individuals should be advised to seek immediate medical attention should they experience new onset of chest pain, shortness of breath or symptoms of arrhythmia.
Issue Number: WN00018