WHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work

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1 WHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work Dr Drew Meek Prequalification Team Regulation of Medicines and other Health Technologies Essential Medicines and Health Products World Health Organization Geneva, Switzerland

2 Location in the organization: Department of Essential Medicines & Health Products in Health Systems and Innovation Cluster Essential Medicines and Health Product [EMP] Policy, Access and Use [PAU] Regulation of Medicines and other Health Technologies [RHT] Public Health, Innovation and Intellectual Property [PHI] Technologies Standards and Norms [TSN] Regulatory Systems Strengthening [RSS] Prequalification Team [PQT] Safety and Vigilance [SAV]

3 Structure of the Prequalification Team Prequalification Team Coordinator Coordinator s office Vaccines Assessment Medicines Assessment Diagnostics Assessment Inspections Technical Assistance/Labs Administrative team

4 Role of WHO prequalification Facilitate access to safe, appropriate priority IVDs, medicines & vaccines Support two of WHO's six core functions setting norms & standards / promoting their implementation providing technical support, catalyzing change & building institutional capacity Contribute to achieving four of WHO's impact goals reduce under-five mortality reduce maternal mortality reduce the number of people dying from AIDS, tuberculosis and malaria eradicate polio

5 WHO Goal for vaccines regulation Ensure that 100% of vaccines used in all national immunization programmes are of assured quality Definition of Vaccines of Assured Quality National Regulatory Authority (NRA) independent from vaccine manufacturer & procurement system NRA is functional (system + 6, 4 or 2 regulatory functions implemented) No unresolved reported problem with vaccine WHO guidance by Experts Committee on Standardization of Biologicals (ECBS) recommendations on safety, efficacy and qualityissued in WHO Technical Report Series (TRS)

6 WHO concept of Vaccine Regulation National Regulatory System : Governance + six regulatory functions 1. Marketing Authorization (MA) and Licensing Activities 2. Post-marketing activities including surveillance of Adverse Events Following Immunization (AEFI) 3. NRA Lot Release 4. Laboratory access 5. Regulatory Inspections 6. Authorization/Approval of Clinical Trials

7 Required functions according to vaccine source Vaccine Source MAA & licensing PMS Lot release Lab access Regulatory Inspections Authorization & monitoring CT UN agency supply Direct purchase Producing country Regulatory System Exporting country NRA + WHO-PQ Exporting Country NRA All countries where CTs are performed Slide 7

8 Review of past PQ applications- main issues identified Quality Clinical Programmatic GMP Incomplete dossier Lack of data at commercial scale No history of characterization and Working cell banks Novel devices: nasal administration Lack of clinical consistency data, unclear ethical oversight Clinical trial comparator product not acceptable Lack of access to data and/or old data not meeting current GCP Deviation from Programmatic suitability criteria (PSPQ): e.g., nonautodisable prefilled syringes, stability profile and VVM Quality Systems Manufacturing process Lack of registration of CTs Regulatory National Vs WHO requirements: Test methodologies and GMP Schedules and target population Monodose Vs multidose presentation (preferred)

9 Programmatic suitability criteria Publication of PSPQ criteria and establishment of Standing Committee on PSPQ Briefing on PQ expectations (workshops and webinar) Guidance documents Pre-submission meetings Quality, safety and efficacy Regulatory Collaboration agreements with National Regulatory Authority of record for PQ Consolidated investigation, reporting and communication in response to quality or safety concerns Post-PQ monitoring

10 Collaborative National Registration of Prequalified Vaccines

11 Principles of the Collaborative Registration procedure 1. Procedure is voluntary for manufacturers and NRAs and provides benefits to both parties. 2. With consensus from manufacturer, full PQ PSF and site audit report plus initial testing results will be shared with interested NRAs to facilitate national regulatory decisions making (registrations, variations, withdrawals). 3. No interference with national legislation, decision making process and regulatory fees but PQ expertise is available to NRAs.

12 Principles of the procedure (2) 4. Since there is agreement to share reports, the registration dossier should be, in-principle, the same as the PSF approved by PQ. 5. Each participating authority commits to adopt the registration decision within 90 days after having access to full PQ reports. 6. The NRA has the right to: decline to adopt the procedure for specific products decide differently from PQ, but keep PQ informed and clarify the reasons for deviation.

13 Collaborative Registration Key elements: Agreement NRA confirms to WHO PQ its interest to participate in collaborative procedure and respect its conditions One or two focal persons are designated at each interested NRA, sign confidentiality undertaking and are given access to the WHO managed restricted access

14 Collaborative Registration Key elements: Registration Applicant submits dossier to NRA as per national procedures (content should be the same as that in the PSF) Applicant pays fees to NRA as per national rules Applicant informs WHO and gives written consent for WHO to share information NRA makes a decision and informs PQ

15 Post-registration Variations are communicated from WHO to NRA If national rules on variations differ from WHO-PQ variations NRA will inform PQ WHO-PQ informs NRA about withdrawals, suspensions, delisting.

16 Win-win situation NRAs Availability of WHO assessment and inspection outcomes to support national decisions Opportunity to learn from PQ assessors and inspectors Saving internal capacities WHO and UN agencies Prequalified vaccines are available sooner Feed-back on WHO prequalification outcomes Manufacturers Harmonized data for PQ and national registration Accelerated and more predictable registration

17 JOINT reviews for priority products: polio and influenza DATA SHARING and DIRECT PROCUREMENT Self procuring countries (of WHO prequalified vaccines) are requesting access to WHO assessment data outside collaborative registration procedure Need for company agreement No WHO influence over national registration timeline.

18 POLIO END GAME

19 Polio End Game strategy SAGE recommendations Reaffirmed April 2016 for the globally synchronized withdrawal of type 2 OPV. Concluded that preparedness criteria for the switch are largely met Public health risks associated with the continued use of the type 2 component contained in topv far outweigh the risk of new VDPV2 emergence after OPV2 is stopped, including in countries where IPV introduction will be delayed. Vaccines All 6 prequalified bopv are licensed for use in routine immunization by their respective NRA Global stockpile to respond to type 2 polio outbreaks following withdrawal Switch to IPV Slide 19

20 Containment of type 2 poliovirus: goal Goal: prevent transmission of PV2 from facilities to people Phase I: Reduce the number of facilities containing PV2: Destroy unneeded PV2 WPV2 by end-2015 Sabin2 by July 2016 Designate poliovirus-essential facilities for needed PV2 Phase II: Reduce risk in remaining facilities: Ensure appropriate containment of PV2 in poliovirus-essential facilities 20

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23 Thank you and questions