WHO Regulatory Systems Strengthening Program

Transcription

1 WHO Regulatory Systems Strengthening Program MVP RHT RSS CRS

2 Minimal capacity met Eligibility for vaccine PQ WHO listed NRAs WHO NRA 5 step capacity building Development of NRA benchmarking tool Benchmarking of NRA Formulation of Institutional Development Plan (IDP) Providing technical support, Training/Learning, networking, Monitoring progress and impact

3 WHO Global Benchmarking Tool Structure/Hierarchy National Regulatory System (NRS) and Functions (NRF) SYSTEM FUNCTION INDICATORS 1. Regulatory System + Common Function 2. Non Common Functions SUB-INDICATORS QUESTIONNAIRE FOR OTHER PRODUCTS /ACTIVITIES Common Function 01-NATIONAL REGULATORY SYSTEM 02-REGISTRATION AND MARKETING AUTHORIZATION 03-VIGILANCE 04-MARKET SURVEILLANCE AND CONTROL 05-LICENSING PREMISES 06-REGULATORY INSPECTION 07-LABORATORY ACCESS AND TESTING 08-CLINICAL TRIAL S OVERSIGHT Non Common Functions THE FACT SHEET 09-NRA LOT RELEASE 05/10/2018 3

4 WHO GBT ISO 9004 WHO GBT Performance Maturity Levels No formal approach Reactive approach Stable formal system approach Continual improvement emphasized Some elements of regulatory system exist Evolving national regulatory system that partially performs essential regulatory functions Stable, wellfunctioning and integrated regulatory system Regulatory system operating at advanced level of performance and continuous improvement Can be consider as functional if rely on other regulators for some specific functions Target of WHA Resolution Advanced/reference Regulatory Authorities 99 COUNTRIES 45 COUNTRIES 50 COUNTRIES 4

5 Update on WHO Global Benchmarking Tool 5

6 Public consultation of WHO GBT 6

7 Roadmap for phasing in GBT revision VI WGs F2F meeting Edit the GBT draft revision VI Publish summary of comments and responses Pilot the GBT draft revision VI Final adjustment, editing and publication of GBT revision VI Translate and publish GBT revision VI in Spanish and French Phasing in of GBT revision VI Jul Aug Sep Oct Nov Q

8 Major changes from GBT revision V to VI Maturity levels from 1 to 4 (ML5 removed) Revised indicators: merging; further clarity and consistency; shift in ML assignment Modified rating scale and algorithm for maturity level determination Agreement on assessment of degree of implementation of processes and procedures Expanded guidance: comprehensive fact sheets to guide assessors and NRAs (including detailed guidance on rating, limitations and remarks) Readability and consistency: harmonized language and editing

9 Update on WHO Listed Authorities 9

10 WHO Listed Authority Term Stringent Regulatory Authority, defined as original ICH member/observer, was developed to promote reliance and guide procurement decisions - widely used and recognized However, growing recognition that change required, with interim definition endorsed by WHO Expert Committee at 51 st meeting (Oct 2016) based on membership of original ICH Concerns with term SRA; with the fact that ICH is a harmonization initiative for pharmaceuticals, not a body with a remit or competence to assess regulatory capacity; coupled with expanding membership Experts at 52 nd meeting (Oct 2017) considered new WHO proposal and comments received, made a number of recommendations 10

11 Expert Committee Recommendations Term SRA be replaced by WHO-Listed Authority (WLA) Currently identified SRAs will be regarded as WHO- Listed Designation of additional NRAs be based on WHO Global Benchmarking Tool (GBT) + completion of confidence-building process Procedure for listing be developed through usual public consultation process 11

12 Establishing a system for recognizing and listing WLA Concept note under development that will present proposed definition for WLA define proposed criteria and process for designating an NRA as WLA describe the proposed process and timelines for finalizing the definition and process for designating a WLA Given implications, WHO intends to undertake a broader consultation process Targeting early 2019 for adoption, together with introduction of WHO Global Benchmarking Tool (version VI) Transition phase foreseen Definition must be assessed in context of existing WHO guidelines 12

13 Considerations Voluntary process undertaken at request of country with the understanding that outcome (but not details) to be made public Process must be transparent, practical, flexible and equitable WLA will include both ML 3 and ML 4 agencies. Listing will specify. Transparent process for renewal, including of former SRAs, will be developed taking into account existing assessments and evidence Must ensure continued supply of quality assured products for use by UN procurement agencies and countries WLA designation not intended to affect regional designations 13

14 Benefits Provide a robust framework to promote trust, confidence and reliance and thereby enable efficient use of regulatory resources Encourage continuous improvement of regulatory systems Help guide procurement decisions on medical products by UN and other agencies, as well as countries: global quality reference for international and domestic supply, including for products not eligible for PQ Expand the pool of regulatory authorities contributing to efficiency of Prequalification programme and the efficiency of the PQ process and listing Essentially means that marketing authorizations for WLAs would be taken into account by PQT in a manner to be defined 14

15 WHO-Listed Authorities ML 3 authority: Target of WHA resolution 67.20: well-functioning system Equates with former functional designation Remains prerequisite for vaccine manufacturer application to PQ Status could also be taken into account for medicines ML 4 authority: Equates with SRA Could be for a specific program (generic medicines) or regulatory function (Inspection) Allows for abridged procedure, depending on scope of WHO evaluation 15

16 Evaluation framework Robust assessment using relevant components of GBT + Confidence building exercise or enhanced performance verification to confirm consistency in performance against international standards and best practices 16

17 WHO Regulatory Harmonization and Networking 17

18 WHO views on Regulatory Cooperation Convergence & harmonizatio n Recognition Reliance Work-sharing Reliance Recognition Information-sharing 18

19 Why WHO Supports Regulatory Convergence and Harmonization? Potential for savings/greater reach via generic equivalents and increased competition Healthcare resources can be better managed Improved public health outcomes National Government Increased capacity More timely & cost effective evaluation processes Greater regulatory network, sharing of best practices & experiences More effective medicines control Manufacturers (Local and International) NRAs Donor Community Greater process transparency Reduced regulatory burden Shorter time to approval Greater incentive to prioritize dossier submissions Improved access to regional markets Patients / consumers Quicker access to more affordable medical products of assured quality, especially for priority medicines Improved assurance that available medical products are safe Higher patient reach for a given level of support 19

20 Conclusions Regulatory capacity building, promotion of collaboration, convergence and harmonization will continue to be one of the WHO priorities; Harmonization means nothing if the established common guidelines are not implemented. There is no good regulation without Good Governance (accountability, transparency, fair and equal treatment of all regulated parties etc.); Making medicines is no longer a "local" business and the era of locally operating regulators is coming to an end; 20

21 Important Links Go to our Regulatory system strengthening website Go to the Global Benchmarking Tool Go to SharePoint site Go to GBT online training 21

22 Thank you Dr Alireza Khadem Regulatory Systems Strengthening (RSS) Regulation of Medicines and Other Health Technologies (RHT) World Health Organization (Geneva, Switzerland)