Transcript document Overview of regulatory capacity and NRA priorities based

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 that require
NRA to make publicly-available
registered pharmaceutical
products with defined
periodicity*
52%
No
48%
Yes
*Source: Results based on data from 27 American countries/PRAIS
Legal provisions to NRA to
publish the Summary
Product Characteristics
(SPCs) of registered
pharmaceuticals*
70%
No
30%
Yes
Legal provisions that allow the
sampling of imported products for
testing*
Yes: 89%
No: 11%
*Source: Results based on data from 27 American countries/PRAIS
Routine and crisis
communication strategies*
Legal provisions for clinical
trials authorization*
No
48%
52%
No
Yes
48%
*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: E-mail 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
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
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*
60%
50%
40%
30%
20%
10%
0%
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
Does your NRA have a training program
designated for the staff development in core
regulatory functions?
Do you consider the training program is
meet the current staff needs?
Yes
31%
Yes
37%
No
69%
No
63%
Does your NRA has a management
training program?
Yes
34%
No
66%
Do you consider the training program
meet the staff current needs to manage
the your NRA resources?
No
33%
Yes
67%
Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013
RESULTS
PART II: OFFERS OF TRAINING/COURSES AND NRA
STRENGTHENING CAPACITIES
Comment/suggestions related to training offers and the NRAs current needs*
*Results are based in responses from 5 countries, 2013
RESULTS
PART III: MECHANISMS OF COOPERATION IN THE PAN AMERICAN REGION
In the past two years, has your NRA
participated in an agreement of
cooperation with another NRA of the Pan
American Region?*
In the past two years, has your NRA
participated in an agreement of
cooperation with other international
institutions (excluding agreements with
PAHO and other NRAs)?*
Yes
14% **
**
No
40%
Yes
62%
No
86%
**USAID, USP, UNFPA, PNUD
*Source: PANDRH survey on current and future regulatory challenges in the Americas, 2013
CONCLUSIONS
• Future regulatory priorities/challenges for products and functions*:
Medical Devices
Medicines Counterfeit combat
Biotechnologics
BE/BD
Vaccines
Import/export control
Herbal Medicines
National Lab Quality Control
Blood derivatives
Pharmacovigilance
• 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
THANK YOU!