South East Asia Regulatory Network SEARN for access

South East Asia Regulatory Network – SEARN for access to quality, safe and affordable Medical Devices and diagnostics Dr Manisha Shridhar Regional Advisor WHO-SEARO Disclaimer: No Conflict of Interest 1 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 1

Regulatory and Trade Context is different in different Medical Products Medicines (relatively well established) , Vaccines (well established ‘closed’ system), diagnostics (developing), devices (developing ) Drug Regulatory Authorities largely Pharmacists for medicines Match roles to requirements of different product- product obsolescence in devices Challenges in use: role of pharmacies in drugs certain use by the patients/ people themselves - with little or no medical information- instructions and labelling requirements – manufacturers seen as responsible Supply line challenges- storage – role of regulators and regulation 2 Assist limited liability to the manufacturer Other Organization statutes and rules e. g. Customs organization 4 th WHO Global Forum on Medical Devices Role of courts – robust interpretation of laws of contract – ‘Increasing Access to Medical Devices’ encourage legal awareness 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 2

Regulation of medical devices ‘Medical devices’ originally regulated as medicines, e. g. , sutures 1976: US medical device amendments to Federal Food, Drug and Cosmetic Act Established devices Center Comprehensive regulatory framework Risk-based classification Pre- and post-market controls European Community medical device directives in early to mid-90 s 3 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 3

Global Harmonization Task Force (GHTF) 1993: Global Harmonization Task Force (GHTF) founded in 1993 by governments and industry An early example of partnership – public private partnership (PPP) Mode in public health (1990 International Council for Harmonisation (ICH) bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration). Founding members: Australia, Canada, Japan, the European Union, and the United States of America GHTF to encourage convergence in standards and regulatory practices Goals: safety, performance and quality of medical devices Promote technological innovation and facilitates international trade Methodology: publication and dissemination of harmonized guidance documents 4 th for. WHO basic regulatory practices Global Forum on Medical Devices 4 ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 4

Medical devices are special – SEARN context Map existing resources – facilities etc. (listing of key expertise and knowledge already there? )/ regulatory capacity Task division and sharing Procedures for reliance on what others are doing Adoption of PQ/ Abbreviated PQ procedures- [ PQ is an assessment in time] Region specific responses Opportunities for learning specialized knowledge Collaborative procedures to forge reliance? Strengthen key areas Track industry trends in mergers and acquisitions – intelligence through the market place – ISO Certifications Ensure consistency in quality of products Putting a dossier together Post marketing surveillance / vigilance of medical products – efficient migration of information from disease programs to regulatory reporting systems Problems with product/ use of product? 5 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 5

Elements of medical devices regulatory systems Definition of ‘medical device’ Registration of manufacturers, importers, and distributors and devices placed on national market Risk-based classification system and controls Quality management system/GMP requirements Requirements for safety, performance, and quality Labelling requirements and trade requirements Clinical evidence requirements Oversight/controls for clinical investigations Recognition of standards- national/ international Pre-market conformity assessment Post-marketing surveillance, adverse event reporting, field safety corrective actions/recalls 6 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 6

Critical for achievement of health and other SDGs 7 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 7

Access to Medical products is in SDG -3 The SDG 3 emphasises the promotion of health throughout the life course and universal health coverage (UHC) Expand access to quality assured medicines and health products Ensure that quality essential medicines and health products are available in sufficient quantities and affordable to the population through functioning regulatory and procurement systems Focus on research and development efforts on diseases that disproportionately affect developing countries 8 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 8

4 September 2018 – Ministerial Round table on Access to medical products in South-East Asia Regional Committee 9 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 9

Delhi Declaration- Access to Medical products (medicines, vaccines, devices, diagnostics) 10 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 10

South East Asia Regulatory Network ( SEARN) Main Objective: Information sharing: Create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities as approved by Network members. Formation of Steering Group and Working Groups for Quality assurance and standards of medical products, including labs Good Regulatory Practices (GRP) including GMP, GDP etc. Vigilance for medical products Medical devices and Diagnostics Information Sharing Platform 4 th WHO Global Forum on Medical Devices 11 ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 11

Working Group 5: Medical devices and diagnostics Map medical device regulations for SEARN countries for current situation Map capacity building needs for each country Enhance capacity inquality control of Medical devices and diagnostics 12 4 th WHO Global Forum on Medical Devices ‘Increasing Access to Medical Devices’ 13 -15 December 2018, Visakhapatnam, Andhra Pradesh, India 12