Developing further cooperation between the Heads of Medicines Agencies (HMA) and the Competent Authorities for Medical Devices (CAMD) networks

Introduction

  1. The UK and Ireland are currently leading a project looking at the development of cooperation between the HMA and CAMD networks at a strategic level. This has been considerd on a number of occasions but it is now more relevant and timely than ever:
  • Both sectors have and will experience continued change over the coming years faced with changing regulatory environments, increased expectations, resource and expertise challenges and increased uncertainties in global economic and political influences.
  • Heightened public awareness and expectation around health product safety and performance issues. Trust needs to be built, or rebuilt, in regulatory systems faced with real or perceived confidence issues. Both sectors must increasingly engage with the clinical community to build partnership, increase relevance, access expertise and identify relevant practice issues.
  • Health products are also becoming increasingly interdependent as technologies converge. This adds to the regulatory complexity of addressing combination products but also broadens the number of interfaces and borderlines with different regulated sectors (drugs, devices, in-vitro diagnostics, software/e-health, ATMP, tissues & cells, food).
  • Existing paradigms are challenged not only by converging technologies but the emergence of new technology areas including: software and connected health technologies; additive manufacturing; customised health products, aesthetic and assistive products, artificial intelligence and clinical decision systems.
  • The impending changes to medical device and IVD regulations have impacts on both sectors as these will raise new borderline issues and clarity is required around regulatory roles and pathways for combination products (including companion diagnostics). Ensuring that the systems are appropriately ‘joined-up’ and operationally efficient will benefit both patient safety and innovation.
  1. The medical device and pharmaceutical regulatory systems are necessarily distinct due to the nature of the technologies, the diversity and number of medical devices and the differences in the ways in which the technologies are used. Nevertheless there are many horizontal elements and synergies which already exist or can be further exploited. Currently around 70% of competent authorities hold joint responsibility for medical devices and medicinal products. Any cooperation between the sectors should ensure equal inclusion of the representative heads from standalone authorities.

Specific challenges

  1. Detailed below are a series of specific issues where cooperation between the medicines and medical devices sector is would appear mutually beneficial and will improve regulatory effectiveness and efficiency. This will also be important to address emerging technologies and regulatory challenges.

Element / Detail
Borderline products / Qualification/determination
Substance based devices / Pre-market assessment & process requirements
Combination products / Medicines
-Existing technologiesDrug device combinations – appraisal of devices component for marketing authorisation
-Clinical research – integrated approach
-cATMP
-unlicensed use of medicines with CE markeddelivery devices
Devices
-Existing technologies device-drugcombination – appraisal of medicines components – NB consultation to medicines CAs
-Clinical research – integrated approach
Tissues & cells/blood / ATMP
Devices combined with non-viable cells and tissues – consultation with Cells nad Tissues CAs
Devices with human cells or blood derivatives
Interface with Human Tissue regulation
Near-patient manufacturing / Additive manufacture (e.g. 3D printing)
Specials manufacturing
Cell therapies
“ Point of Use Manufacture”
Companion diagnostics/biomarkers / Co-development of Drug-IVD evidence/data
Marketing authorisation/CE marking of companion diagnostic
Vigilance/pharmacovigilance / Interface for combinations
Signal detection systems & methods
Risk-benefit communication
Benefit-risk assessment
Clinical research / Common elements/synergies in assessment of clincial research
Common elements, effeciencies and learnings from implementation of CTR and MDR
Application of GCP to medicines and device research
Global harmonisation initiatives / Strategic & operational opportunities
ICMRA/IMDRF
MDSAP/JAP
Nomenclature – product, disease, outcome, failure mode etc
Supply chain integrity / GDP
Counterfeit
Compliance/enforcement initiatives – Pangea
Software/apps/AI / Diagnosis
AI = impact of AI on both medicines and devices
Wearable / connected health/closed loop / Diagnostic/therapeutic systems
Self-diagnosis, home monitoring, self-care & treatment
Artificial pancreas
Horizon scanning for new technologies / Emerging technologies
Regulatory science

Next steps

  1. There will be a meeting between the CAMD and HMA on 30 November where we plan to identify areas that should be a priority for specific action amongst authorities. Before this meeting we would be grateful for input from key industry stakeholders on the following questions:
  • Is the list above complete?
  • Where should be the areas that authorities should focus on first? If you were to pick two or three areas what would they be?
  • Are there any specific outputs from this work you would expect?
  1. We would be grateful for input by Monday 6 November to Natalie Richards ().