Tower Mains Weekly Newsletter
Company Updates
Meet our Senior Associate, Rosemary Ichaba
Rosemary was introduced to QA after completing a Masters in Drug Discovery and Pharma Management and from here she branched out into Project Management, working within a Global CRO for two and a half years. Following this, she became QA Facilitator/Auditor in a research organisation before joining Tower Mains as a Senior Associate in 2022. Click here to find out what initially attracted her to QA, her career highlights, and what makes her tick outside of work.
Regulatory Updates
MHRA guidance updates
- Export medical devices: On 27th March, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to order certificates of free sale to export medical devices outside the UK. Click to view source
- Registering medical devices to place on the market: On 27th March, the MHRA updated information in its guidance on how to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland. Click to view source
- Registering medical devices to place on the market: On 28th March, the MHRA published good clinical practice (GCP) inspection metrics for 2019-2020. Click to view source
FDA guidance updates
- FDA issues draft guidance aimed at improving oncology clinical trials for accelerated approval. On 24th March, the US Food and Drug Administration (FDA) published draft guidance to discuss the design of clinical trials, and ways to improve the data available at the time of accelerated approval and reduce clinical uncertainty for patients by initiating post-marketing confirmatory studies promptly. Specifically, the guidance addresses the design, conduct and analysis of data through two randomised clinical trial approaches – conducting two separate randomised controlled clinical trials or using one trial for both accelerated approval and to verify clinical benefit. Click to view source
- Transition plan for medical devices that fall within enforcement policies issued during COVID-19 emergency. On 27th March, the FDA released final guidance to provide its recommendations and expectations to manufacturers of devices that fall within certain enforcement policies issued during the COVID-19 public health emergency to transition to normal operations when the public health emergency declaration related to COVID-19 under section 319 of the Public Health Service Act ends. Click to view source
- Transition plan for medical devices issued emergency use authorisations related to COVID-19. On 27th March, the FDA announced the availability of a final guidance to provide recommendations and expectations to manufacturers of devices that were issued emergency use authorisations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for the FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act ends. Click to view source
- Animal studies intended to evaluate Medical Devices. On 28th March, the FDA released final guidance to provide recommendations on animal studies intended to evaluate medical devices intended for human use, when a suitable alternative to an animal study is not available. This guidance specifically applies to animal studies intended to assess device safety, which may include performance and handling, in premarket submissions to FDA. Click to view source
- Cybersecurity in Medical Devices: Refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act. On 30th March, the FDA issued final guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act. The agency generally intends not to issue “refuse to accept” (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on the information required by section 524B of the FD&C Act. Instead, the FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process. Click to view source
EU grants extension of CE certificates
On 28th March, the MHRA announced that the EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new arrangements recognise the challenges in capacity across notified bodies. Key changes include:
- Extension of the transitional period for higher-risk devices, such as pacemakers, to comply with EU MDR requirements until 31 December 2027, subject to certain conditions.
- Extension of the transitional period for medium and lower-risk devices, such as syringes, to comply with EU MDR requirements until 31 December 2028, subject to certain conditions.
These changes to the EU MDR apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.
Industry Updates
ICH Q9(R1) Introductory Training Presentation is now available
On 20th March, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a Step 4 Introductory Training Presentation developed by the Q9(R1) Expert Working Group, following the ICH Q9(R1) Guideline on Quality Risk Management reaching Step 4 of the ICH Process in January 2023.
MHRA issues recommendations following terlipressin trial
On 23rd March, the MHRA issued recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known and that terlipressin increases the risk of sepsis and septic shock. The CONFIRM trial was a phase 3 clinical trial conducted in the USA and Canada, comparing the efficacy of terlipressin plus albumin with that of placebo plus albumin in the treatment of type 1 hepatorenal syndrome.
FDA releases framework for the use of digital health technologies in product development
On 23rd March, the FDA released framework for the use of digital health technologies (DHT) in drug and biological product development to guide the agency’s multifaceted DHT program for drugs and biological products. The program will engage stakeholders and include workshops and demonstration projects; establish internal processes to support DHT evaluation for use in drug development; promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development; and facilitate the publication of relevant guidance documents.
MHRA issues Drug Safety Update newsletter for March 2023
On 26th March, the MHRA published the March issue of its monthly Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines (CHM).
Click to view source View PDF newsletter
IOnctura awarded UK’s MHRA Innovation Passport
On 28th March, iOnctura, a clinical-stage biotechnology company developing breakthrough therapies for patients suffering from cancer, announced that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, for the treatment of metastatic uveal melanoma by the MHRA. The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market and thereby patient access to novel treatments in the UK. Reserved for innovative therapies for life-threatening or seriously debilitating conditions, ILAP provides applicants with a toolkit to support all stages of the design, development, and approval process.
DARWIN EU® completes first studies and is calling for new data partners
On 28th March, the European Medicines Agency (EMA) announced that DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has had a successful first year. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded, and the network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines. In 2023, the network plans to onboard ten additional data partners and initiate around 16 studies that will collaborate with the DARWIN EU® Coordination Centre to enable analyses of their data to deliver RWE. For more information visit the DARWIN EU® website.
Issue Number: WN00105
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