Industry Insights

Our Industry Update Newsletter returns for the third update of 2024.

As always, this quarter’s update has been expertly compiled by Christina Hägglund, QA Manager.

WORLDWIDE INITIATIVES FOR CLINICAL TRIALS

EU Initiatives

The European Forum for Good Clinical Practice and the European Federation of Pharmaceutical Industries and Associations introduces the EU-X-CT cross-border clinical trials initiative which aims to enhance access to cross-border clinical trials in Europe. 20240702-euxct-psf-24- report.pdf (efpia.eu)

One Health is a framework which recognises the complex interplay between human, animal and plant health, food safety, climate crisis and environmental sustainability. One Health: a joint framework for action published by five EU agencies | European Medicines Agency (europa.eu)

ACT EU launches two new pilot programs in the second half of 2024, offering:

  • Harmonisedscientificadvicetosupportthesubmissionofmarketingauthorisationand clinical trial applications in the EU
  • Consolidated technical/regulatory advice on clinical trial application dossiers prior to their submission to Clinical Trials Information System (CTIS)

EUROPEAN MEDICINES AGENCY – Consolidated advice pilots (europa.eu)

On 23 April 2024, the European Medicines Agency (EMA) published recommendations to address vulnerabilities in the EU supply chains of critical medicines, recommending:

  • Marketing authorisation holders (MAHs) to increase manufacturing capacity, diversify suppliers, and monitor forecasts of medicines supply and demand & available stocks in the entire supply chain
  • MAHs to establish a shortage prevention plan for medicines listed as critical
  • Certain parties to stockpile medicines to protect against fluctuations in demand or supply
  • Provision of scientific and regulatory support to address vulnerabilities in the supply chain

New recommendations to strengthen supply chains of critical medicines | European Medicines Agency (europa.eu)

On 23 May 2024, the European Commission (EC) adopted new rules for Joint Clinical Assessment of medicines, aiming for faster access to medicines for EU patients. Joint Clinical Assessments will start in January 2025 for medicinal products with new active substances for treatment of cancer and for advanced therapy medicinal products. Implementing regulation – EU – 2024/1381 – EN – EUR-Lex (europa.eu)

US Initiatives

On 29 May 2024, the Food and Drug Administration (FDA) began a pilot program entitled Support for Clinical Trials Advancing Rare Disease Therapeutics. Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program | FDA

FDA proposes to amend its human prescription drug product labelling regulation with a new guide ‘Patient Medication Information’ (PMI), aiming at improving adherence to over the counter medicines. Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information | FDA

FDA plans to create a Rare Disease Innovation Hub. FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients | FDA

FDA and the Clinical Trials Transformation Initiative (CTTI) want patient advocates to join their Patient Engagement Collaborative (PEC). A discussion forum for patient communities and FDA staff will be available via PEC. 2024-15008.pdf (SECURED) (govinfo.gov)

Center for Drug Evaluation and Research (CDER) launches Center for Clinical Trial Innovation (C3TI), a central hub that supports innovative approaches to clinical trials designed to improve the efficacy of drug development. CDER Center for Clinical Trial Innovation (C3TI) | FDA and Frequently Asked Questions about CDER Center for Clinical Trial Innovation (C3TI) | FDA

UK Initiatives

Health Research Authority (HRA) have made recommendations on how to improve clinical research for participants, via ‘people centred’ clinical research; people may be asked to take part in testing a new treatment, using a device or by being cared for in a certain way. People- Centred Clinical Research – Health Research Authority (hra.nhs.uk)

The Association of the British Pharmaceutical Industry (ABPI) supports innovation to improve care and ease the pressure on the NHS. NHS Confederation and the ABPI: Collaborate to innovate

Medicines and Healthcare products Regulatory Agency’s (MHRA’s) New Notification Scheme for Phase III and IV for accelerated approval. Innovation in regulation is shortening timelines for lowest risk clinical trials – Case study – GOV.UK (www.gov.uk)

Regulations & Guidelines

EU Clinical Trial Regulation (CTR (EU) No. 536/2014)

The CTR Q&A document has been updated to version 6.9: regulation5362014_qa_en_0.pdf (europa.eu)

ICH M12 Guideline of Drug Interaction Studies

ICH M12 guideline will come into effect 30 November 2024: ich-m12-guideline-drug-interaction-studies- step-5_en.pdf (europa.eu) and accompanied Q&A: question-answers-ich-m12-guideline-drug- interaction-studies_en.pdf (europa.eu)

CTIS Transparency Rule

A revision to the transparency rules for CTIS came into effect on 18 June 2024. The revision aims to give:

  • A more appropriate balance between the transparency of information and the protection of commercially confidential information (CCI).
  • Earlier and more efficient access to information about clinical trials in the EU for patients, healthcare professions and other stakeholders.

revised-ctis-transparency-rules_en.pdf (europa.eu) and clinical-trial-information-system-ctis-sponsor- handbook_en.pdf (europa.eu)

UK Research Ethics Committees (RECs)

Two changes have been introduced across the UK:

  • Removal of the requirement to submit an annual progress report
  • RECs acknowledgement of Suspected Unexpected Serious Adverse Reactions (SUSARs) and annual safety reports has changed

Important changes to progress and safety reports – Health Research Authority (hra.nhs.uk)

Real-World Data (RWD) and Real-World Evidence (RWE)

July 2024 – The ICH reflection paper on pursuing opportunities for harmonisation when using RWD to generate RWE, with a focus on effectiveness of medicines. ich-reflection-paper- pursuing-opportunities-harmonisation-using-real-world-data-generate-real-world- evidence_en.pdf (europa.eu)

New Council for International Organizations of Medical Sciences (CIOMS) report on RWD and RWE in regulatory decision making. Real-world data and real-world evidence in regulatory decision making – CIOMS

Guidance – RWE provided by EMA to support regulatory decision making. guide-real-world- evidence-provided-ema-support-regulatory-decision-making_en.pdf (europa.eu)

Draft Guidance

April 2024: FDA ‘Cancer Clinical Trials Eligibility Criteria: Washout Periods and Concomitant Medication’ cct_washout_and_concomitant_meds_draft_guidance_april_2024.pdf (fda.gov)

May 2024: FDA and the National Institutes for Health (NIH) ‘FDA-NIH Terminology for Clinical Research – Glossary of Terms and Definitions Glossary-Terms-for-RFI_Final_Draft.pdf (nih.gov)

June 2024: FDA ‘Processes and Practices Applicable to Bioresearch Monitoring Inspections’ draftgfi_processesandpracticesapplicabletobioresearchmonitoringinspections-frdts2023- 363op5-10-24_final.pdf (fda.gov)

June 2024: FDA ‘Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies’ 2023-413_dap_draft_guidance-6-24-24.pdf (fda.gov)

Medical Devices

Europe

The EMA has issued a revised Q&A document to clarify the regulations governing medical devices:

  • Medical Device Regulation (MDR) ((EU)2017/745)
  • in vitro diagnostic MDR ((EU)2017/746)

questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu- 2017-745-eu-2017-746_en.pdf (europa.eu)

The new Medical Device Coordination Group (MDCG) has issued a guidance on the expected content of an Investigator’s Brochure for clinical investigations of medical devices. mdcg_2024-5_en.pdf (europa.eu)

On 25 June 2024, the EC issued a new guidance document on clinical evaluation of orphan medical devices. mdcg_2024-10_en.pdf (europa.eu)

UK

On 21 May 2024, the MHRA published a statement proposing international recognition of medical devices. The UK Government intends to recognise regulatory approvals from Australia, Canada, EU and USA, which will be dependant on the type of medical device, the class and prior approval. MHRA announces a proposed framework for international recognition of medical devices – GOV.UK (www.gov.uk)

On 09 May 2024, the MHRA launched Artificial Intelligence (AI) Airlock. AI Airlock aims to enhance the collective (MHRA, clinicians, patients and others) understanding of AI technology. AI Airlock was deemed necessary due to the increased number of AI medical devices (AIaMD). MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence – GOV.UK (www.gov.uk)

US, Canada and UK

On 13 June 2024, the FDA, Health Canada and MHRA issued a Guiding Principle on ‘Transparency for Machine Learning-Enabled medical devices’. Transparency for machine learning-enabled medical devices: guiding principles – GOV.UK (www.gov.uk)

Australia

The Therapeutics Goods Administration (TGA) in Australia is now able to proactively monitor the highest risk medical device clinical trials, following a change in regulation. Proactive monitoring of highest-risk medical device clinical trials | Therapeutic Goods Administration (TGA)

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Thank you for taking the time to read this Industry Update from S-cubed

Prepared by: Christina Hägglund, QA Manager, S-cubed Ltd Email: christina.hagglund@s-cubed.co.uk



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