October 2023

CORE Reference 2023 Utility Survey

The CORE Reference Project Team is conducting a short survey to rate both awareness of the 2016 original open-access resources and perception of the usefulness of the CORE Reference 2022 extended initiative. In April 2022, European Medical Writers Association (EMWA) Special Project designation was conferred with the aim of providing continuous professional development (CPD) to the medical writing community through surveillance of regulatory reporting and public disclosure landscapes. Our regular free bimonthly email news summary provides subscribers with updates on major changes in regulatory reporting and public disclosure requirements from around the world including the EU, Canada, USA and Asia.

The survey is open for 6 weeks and is due to close on 05 December 2023. Please take time to complete the short survey to help support continued provision of relevant CPD for regulatory medical writers. The results of the survey will be published in September 2024 as part of the Transparency and Disclosure issue of the EMWA journal, Medical Writing (MEW).

Please click here to complete the survey.

Medicines and Vaccines

 CTR and CTIS

  1. The new version of the Clinical Trials Regulation (EU) No. 536/2014 Questions & Answers Version 6.6 is now available. Changes made in this version include: review of point 102; new Q&A 7.51; review Q&A 9.4.

  2. EMA has released the following presentations and video recordings:

    1. video recording of the June CTIS Walk-in clinic.
    2. presentation from the June Bitesize talk: How to submit a transitional  trial in CTIS.
    3. video recording of the September CTIS Walk-in clinic.
    4. slides from the Sixth Industry Standing Group (ISG) meeting from 21 September 2023, including an update on ACT EU and CTIS wherein EMA highlights the outcome of public consultation on transparency rules and includes a preview of proposed new publication rules.
    5. updated slides from the August CTIS Bitesize talk: Part 1-only applications and Part II requirements in CTIS.

  3. EMA posted an updated agenda for the CTIS information day scheduled for 17 October 2023.

  4. EMA has adopted revised transparency rules for the publication of information on clinical trials submitted through CTIS. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way. Read the full announcement here. Notably, one of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (for full details see Annex I : Revised CTIS transparency rules). 

    The revised transparency rules will apply after their technical implementation in CTIS, including its public portal, which is expected to be finalised in the second quarter of 2024. The effective date of completion of the process and the entry into application of the new rules will be communicated to the users of the system before they become applicable.

  5.  EMA Management Board: highlights of October 2023 meeting.

  6. CTIS is hosting a walk-in clinic on 15 November 2023.  Participants are able to submit their questions in advance starting 1 November via Slido with the code #clinic2311. Please note the-walk in clinic scheduled for October was cancelled.

  7. A short account of the 2023 RAPS Convergence meeting held 3-5 October in Montreal, reports that EMA official Anabela Marcal has urged transitioning of existing clinical trials to CTIS portal. It was reported that “To date, just 300 transitional trials have been placed in the portal, out of an estimated 4,000 to 6,000 possible trials.” Sponsors must transition existing clinical trials into the CTIS portal by 30 January 2025.

FDA Guidance and News

  1. The FDA has established a new Digital Health Advisory Committee, to be fully operational in 2024, to advise the FDA on issues related to DHTs (artificial intelligence/machine learning [AI/ML], augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software), providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. 

  2. The FDA released a draft guidance Diabetic Foot Infections: Developing Drugs for Treatment to assist sponsors in the clinical development of drugs and clinical trial designs for the treatment of diabetic foot infections (DFIs) without concomitant bone and joint involvement. Comments can be submitted until 18 December 2023.

  3. The FDA released final guidance on “Benefit-Risk Assessment for New Drug and Biological Products” outlining considerations about a drug’s benefits, risks, and risk management options. The guidance includes a section on how patient experience data can be used to inform the benefit-risk assessment.

Transparency and Disclosure Resources and News

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard will hold a webinar entitled “Amplifying Participant Voices: Crafting Respectful, Inclusive and Understandable Patient Materials” on 23 October. Register in advance  here. 

Development Strategy News

  1. As part of the effort to advance innovation in clinical trial design and conduct, the FDA CDER is soliciting public comments on the barriers and facilitators to incorporating successful or promising innovative clinical trial approaches in drug development programs. There is also a planned upcoming public workshop sponsored by CDER and DukeMargolis Center for Health Policy on 19-20 March 2024 to discuss this topic. Comments to docket FDA-2023-N-4489 will be accepted until 19 April 2024, but those who wish their comments to be considered in the discussion at the public workshop must submit them by 19 January 2024. More information can be downloaded from the dedicated Regulations.gov website.

  2. A joint public workshop is to be hosted by US FDA, MHRA UK, and Health Canada covering good clinical practice and  pharmacovigilance compliance on 13-15 February 2024. Participants can attend in person (Maryland, USA) or online. This is a free event and you should register in advance. Details of the event are provided here and a full agenda for the 3 days is provided here. Notably, the event will be recorded and available to registered attendees afterwards. 

  3. TransCelerate are running a brief survey on master protocol (MP) design and implementation “to understand what makes a successful Master Protocol, including insight into challenges related to master protocol design, and for CPT users, if and how the CPT may be used to capture the more complex aspects of master protocols.” Further details and a link to the survey here.

Artificial Intelligence/Machine Learning

  1. Pharmaceutical companies are increasingly using AI to accelerate participants enrolment and to reduce the number of participants needed in clinical trials. This Reuters article provides insights on how pharma companies are doing this and its challenges.

  2. TransCelerate  has interactive tools and resources under their Intelligent Automation Opportunities in Pharmacovigilance Initiative focusing on identifying how intelligent automation technologies can be used to better support execution of pharmacovigilance activities/processes. Check out the available initiative solutions here. 

  3. The WHO has released a new publication listing key regulatory considerations on AI for health. The News Release can be found here.

  4. Joint Heads of Medicines Agencies (HMA)/EMA are holding a workshop on AI - Smart Regulation on a rapidly evolving world on 20 and 21 November 2023. The objectives are to engage stakeholders with keynote speakers on AI developments in technology, policy and potential applications in medicines regulation; inform on the HMA/EMA activities to deliver the stakeholder’s priorities on AI; and discuss with stakeholders and experts on the draft AI reflection paper. Registration open until 4 Nov. Agenda available here.

News from Asia Regulators

  1. The China NMPA’s Center for Medical Device Evaluation released a draft Guideline on Medical Device Real World Study Design and Statistical Analysis (Page in Mandarin) on 28 September 2023. The guideline provides details on the design and analysis requirements based on the experience collected following the release of the Technical Guideline for Application of Real-World Data to Clinical Evaluation of Medical Devices in 2020. Read a third-party article for a brief overview of the highlights of the guideline. It is worth noting that at the current stage of development, real-world evidence in the clinical evaluation of medical devices should be used to supplement existing clinical evidence and cannot replace the current clinical evaluation procedure.

Medical Devices

Medical devices information is kindly compiled by Raquel Billiones.

Updates on the EUDAMED

  1. The European Commission released an update to the EUDAMED Roadmap. The new target date for EUDAMED full functionality is Q2/2027 as a best case scenario. EUDAMED is the IT system developed by the European Commission to implement the EU MDR and EU IVDR. It is also the platform to support transparency and disclosure for medical devices.

  2. A new version of EUDAMED (2.12) was deployed in September 2023. The deployment was accompanied by the release of the the following documents:

Updates from the European Commission and the Medical Device Coordination Group (MDCG)

  1. MDCG 2023-4 Medical Device Software (MDSW) – Hardware Combinations was released in October 2023. This is a guidance on MDSW intended to work in combination with hardware or hardware components.

  2. The manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices was updated as Version 3 and was released in September 2023. 

  3. A Q&A document on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR was released in September 2023.

  4. The September 2023 issue of the EC Newsletter on medical devices can be accessed here.

Updates from The European Association of Medical Devices Notified Bodies (Team NB)

Team-NB launched a press release in October 2023 to call for action for  manufacturers to apply with notified bodies, especially for high-risk IVD medical devices. For class D devices, it is strongly recommended to submit the applications no later than the end of 2023, that will allow technical documentation assessments to start in time.

Updates from MedTech Europe

MedTech Europe released the European Medical Technology Industry Facts & Figures 2023 in October 2023.

Updates from the International Medical Device Regulators Forum (IMDRF)

The IMDRF released in September the final guidance document on Personalized Medical Devices - Regulatory Pathways. 

Updates on Good Machine Learning Practice

In 2021, the US FDA, Health Canada, and the UK’s MHRA jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). GMLP supports the development of safe, effective, and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance.

In October 2023, the 3 health agencies jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed. Check out the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles. 

 

Updates from the US FDA

  1. The FDA released an Electronic Submission Template for Medical Device 510(k) Submissions.
  2. Also check out the updates to the FDA list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. 

Updates from Health Canada

Health Canada released the following in September-October 2023:

  1. Draft guidance for determining medical device application type. This document provides guidance to manufacturers on the different application types listed in the Canadian Medical Devices Regulations.
  2. Draft guidance: Pre-market guidance for machine learning-enabled medical devices.

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