Regulatory Intelligence Digest - November 2023
Latest Regulatory Updates
November 2023
Hello and welcome back to the Boyds Regulatory Intelligence Digest. This month we are sharing the latest guidance and key updates from the regulatory agencies - FDA, EMA, and MHRA.
To discuss any of these updates, please?contact a member of the Boyds Regulatory team who will be happy to help.
Food and Drug Administration (FDA)
FDA establishes New Advisory Committee on Digital Health Technology
A press release announced that this new committee shall advise the agency on issues related to complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The advisory committee is anticipated to be fully operational next year.
Rare Disease Endpoint Advancement Pilot Program
The second round for applications is now open until 31 December 2023 for sponsors with an active investigational new drug (IND) or pre-IND for the rare disease, or sponsors who do not yet have an active development program but have, or are initiating, a natural history study where the proposed endpoint is intended to be studied.
This pilot program offers selected sponsors the opportunity for increased engagement with FDA experts from the Center for Drug Evaluation and Research and/or Center for Biologics Evaluation and Research.
Final Guidance Released
This guidance describes a program at CBER for recognition of Voluntary Consensus Standards relevant to Regenerative Medicine Therapies and how CBER intends to review for recognition in the SRP-RMT.
Final Guidance Released
This guidance pertains to benefit-risk assessments made to support certain regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs), from premarket approval through the post-market setting and includes decisions regarding any regulatory requirements for approval, such as inclusion of a boxed warning in approved labelling, post-marketing study requirements and commitments, and risk evaluation and mitigation strategies.
Final Guidance Released
Highlights FDA’s recommendations for incorporating information into proposed prescription drug labelling for injectable drug products based on weight or body surface, where the range of strengths is in ready-to-use containers and where the entire drug content of the container(s) is intended to be administered to a patient.
Draft Guidance Released for Comment
Here FDA describes factors to consider when assessing whether a single adequate and well-controlled clinical investigation and confirmatory evidence are sufficient to demonstrate substantial evidence of effectiveness. The guidance also provides examples of types of data that could be considered confirmatory evidence and emphasizes the importance of early engagement with the Agency.
Submit comments by 18 December 2023
New Draft Guidance Open to Comments
Quality Considerations for Topical Ophthalmic Drug Products for solutions, suspensions, emulsions, gels, ointments, and creams. The guidance discussed quality considerations that are consistent with the current good manufacturing practice (CGMP) requirements.
Submit comments by 12 December 2023
Draft Guidance Released for Comment
This guidance describes how FDA request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.
Submit comments by 26 December 2023
Public Workshop - Request for Comments
FDA CDER is soliciting public comments on the state of innovation in clinical trial design and conduct, with the goal of better understanding the barriers and facilitators that both internal and external stakeholders face when trying to incorporate innovative clinical trial approaches in drug development programs. Responses will inform the programming for a hybrid public workshop, to be hosted on 19-20 March, 2024.
Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles
FDA, Health Canada and the MHRA jointly identified 10 guiding principles that can inform the development of GMLP, which 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. See related MHRA webpages.
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European Medicines Agency (EMA)
Update: Questions and answers for biological medicinal products
Several new Questions and Answers were added to the webpage on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures of biological human medicinal products.
Updates from the Medical Device Coordination Group (MDCG)?
The MDCG have updated?the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices This document now includes opinions on:? Root canal irrigation solution, temperature sensors embedded in orthopaedic devices for compliance tracking, and system intended to produce sclerosing foam. It also provides rule clarifications on: n-butyl-2-cyanoacrylate based adhesives and custom-made cranial implants.
Portfolio and Technology Meetings
EMA is offering Pharma companies with large medical product portfolios informal, free-of-charge, virtual meetings to identify issues impacting the progress of the product portfolio, capture new and disruptive technology already in use and to anticipate the scientific and regulatory expertise needed to assess future applications with the Agency.
Applications for meetings held in 2024 must be submitted by the 10. November 2023.
Revised Transparency Rules for the EU Clinical Trials Information System (CTIS)
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 (CCI). 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.
PRIME: Priority Medicines
EMA’s PRIME webpage publishes updated versions of the Guidance for applicants seeking access to PRIME scheme ?and Guidance to support the preparation of PRIME meetings, both from 29 September 2023.
Updated Guidance
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure This questions and answers guidance document contains new information on topics such as: Type II variations, post authorisation safety study (PASS), risk management plan, Article 46 paediatric study submission, and marketing status updates.
Newsletter:? Human medicines highlights – Issue 174, October 2023
Primarily addressed to organisations representing patients, consumers and healthcare professionals, this newsletter provides a summary of key information relating to medicines for human use.
Newsletter: Clinical Trials Highlights– Issue 16 September 2023
Provides insights on clinical trials topics, including Accelerating Clinical Trials in the EU (ACT EU) and CTIS.
Medicines and Healthcare products Regulatory Agency (MHRA)
Press Release - Clinical Trial Authorisation (CTA)
New streamlined notification scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation The scheme, which is based on the MHRA’s clinical trial consultation, will see the lowest-risk clinical trials processed by the MHRA in less than 14 days. The scheme only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed to be of lower risk. For more information also see here.
Press Release
MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers which provides a regulator-monitored virtual area for developers to generate robust evidence for their advanced technologies. This world-leading partnership between government, regulators and industry will see advanced artificial intelligence (AI) technology used in NHS settings, with strict safety controls, ahead of navigating regulatory approval.
Apply for a Licence to Market a Medicine in the UK
Recent updates to this webpage were made with the addition of a ?'Checklist and abstract for bioequivalence studies and/or biowaivers' plus a 'Checklist for product information', for established active substance marketing authorisation applications (MAAs) within scope.
Health Research Authority (HRA) – Information for Research Participants
This summer the HRA launched new Quality Standards and Design and Review Principles to improve information for people taking part in research. They will be implemented UK wide and will become mandatory from 1 December 2023. To help organisations prepare, a list of frequently asked questions is now available.
HRA launches a Clinical Trials Bulletin
The Clinical Trials Update, is a new, regular round-up of the latest news on the work the HRA are doing to help make the UK a great place to do clinical trials.