Overview of regulatory capacity and NRA priorities based on PRAIS data and NRA survey Murilo Freitas, Regulatory Affairs Specialist PANDRH Secretariat VII Pan American Network for Drug Regulatory Harmonization Conference Ottawa, Canada September 5-7th, 2013

OUTLINE Background Regulatory challenges of the Americas – PRAIS data: Observatory Tool PANDRH Survey – Methodology – Results – Conclusions

BACKGROUND On March 2013, during the Ad Hoc meeting, the group requested the development of a survey that identifies current and future regulatory challenges in the Region of the Americas On April 2013, the Pan American Network for Drug Regulatory Harmonization (PANDRH) Secretariat designed an electronic survey in response to the request of the Ad Hoc group The survey is divided in three main sections: – Identification of future national regulatory priorities/challenges for the work of PANDRH – Offers of training and NRAs strengthening capacities – Mechanisms of cooperation in the Pan American Region

Core Regulatory Indicators Data Analysis PRAIS Observatory Tool 5 Basic Indicators of 27 Countries (Public information)

Legal provisions to NRA to publish the Summary Product Characteristics (SPCs) of registered pharmaceuticals* Legal provisions that require NRA to make publicly-available registered pharmaceutical products with defined periodicity* 48% Yes 52% No * Source: Results based on data from 27 American countries/PRAIS 30% Yes 70% No

Legal provisions that allow the sampling of imported products for testing* No: 11% Yes: 89% * Source: Results based on data from 27 American countries/PRAIS

Legal provisions for clinical trials authorization* No 48% 52% Yes No Routine and crisis communication strategies* * Source: Results based on data from 27 American countries/PRAIS

PANDRH Survey Current and future regulatory challenges in the Americas

METHODOLOGY Development of survey questions based on the identification of general regulatory and regional aspects (by PANDRH Secretariat) Study type: Ecological/ transversal (unit- cluster of countries) PANDRH Survey development and dissemination: Electronic platform/tool (11 multiple choice, open-ended and close-ended questions) Follow up: and phone calls Phases – Phase 1 - Internal validation: Testing electronic tool and survey content – Phase 2 - External validation: Pilot study in 5 countries Countries were selected based on geographical location and language Participants: High level NRA and International Affairs (if available) representatives – Phase 3 - Launch of survey (June 2013) Survey sent to remaining 33 countries (English and Spanish) Graphs and map show data received until August 28, 2013

RESULTS Survey response rate (results based on responses from 29 countries): Yes 76% No 24% Part I: Identification of future national regulatory priorities/challenges for the work of PANDRH National regulatory challenges identified by countries: Health Technologies Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013

RESULTS (cont.) Part I (Cont.): National regulatory priorities/challenges identified by countries: Technical areas* Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013

RESULTS (cont.) Aspects that might hinder the future performance of regulation in the Americas* *Results are based in responses from 17 countries, 2013

RESULTS PART II: OFFERS OF TRAINING/COURSES AND NRAS STRENGTHENING CAPACITIES Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013 Does your NRA have a training program designated for the staff development in core regulatory functions?

Comment/suggestions related to training offers and the NRAs current needs* *Results are based in responses from 5 countries, 2013 RESULTS PART II: OFFERS OF TRAINING/COURSES AND NRA STRENGTHENING CAPACITIES

RESULTS PART III: MECHANISMS OF COOPERATION IN THE PAN AMERICAN REGION *Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013 **USAID, USP, UNFPA, PNUD **

Future regulatory priorities/challenges for products and functions*: Medical DevicesMedicines Counterfeit combat Biotechnologics BE/BD VaccinesImport/export control Herbal MedicinesNational Lab Quality Control Blood derivativesPharmacovigilance Most countries do not have staff training program and those that do have a training program, do not satisfy NRA professionals´ need Aspects to improve future NRA performance: Regulatory public information availability; Capacities/Training/Evaluation; Crisis management plan; and Verification of the authenticity of regulatory official documents. Current needs: e.g Distance learning *Study limitations: questions do not allow to distinguish countries’ interests/needs from Regional needs CONCLUSIONS

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