You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
Presentation: IGDRP - Mission, scope, how it works
TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Dr Mariana Gebara-Coghlan
- Presented at: ARCS Scientific Congress Canberra
- Presentation date: 10-11 August 2016
- Presentation summary: This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
IGDRP - Mission, scope, how it works
Dr Mariana Gebara-Coghlan
Director, Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Health Products Regulation Group, TGA
ARCS Scientific Congress Canberra 2016, 10 August 2016
Slide 1 - Outline
- Operating Principles
Slide 2 - Concept
- Access to affordable, quality generic drugs increasingly important in containing health care costs
- Effective coordination for multiple initiatives on a number of fronts
- Form an international collaborative effort in the area of generic drug review
- Followed a step-wise approach:
- started by assessing feasibility and interest in such a concept through discussions with regulatory authorities and multinational generic companies
Slide 3 - Concept (cont'd)
- Timing was right:
- Common requirements in some areas and format provided by ICH (CTD) guidelines
- Increasing prevalence of multi-national generic companies, including generic arms of brand name companies
- Success of existing models:
- EU's De-Centralised Procedure (DCP) and Centralised Procedure (CP)
- WHO's Pre-Qualification Programme
- OECD (new pesticides)
- Restricted set of scientific disciplines (as compared with new active substances)
Slide 4 - History
- Exploratory meeting: Ottawa, November
- Launch of 3 year Pilot: Washington, April
- Nanchang, December
- Canberra, May
- Geneva, October
- Yilan, May
- Singapore, November
- Transition to Programme: Pretoria, May
- Seoul, November
- Strasbourg, May
Slide 5 - Mission and goal
- Promote collaboration & convergence in generic drug regulation to strengthen the ability of health authorities to meet their respective mandates
- Facilitate efficient use of resources and timely authorization and availability of efficacious, safe and quality generic products
Slide 6 - Objectives
- Create conditions which enable greater inter-agency collaboration.
- Foster peer discussion to bring a broader set of perspectives to bear on scientific and regulatory issues.
- Promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices
- Enhance and better coordinate the international regulatory oversight of generic drug products.
- Promote the adoption of modern science- and risk-based approaches to the development and regulation of generic drug products.
- Promote increased efficiency, consistency and predictability in regulatory assessments and decisions.
Slide 7 - Objectives (cont'd)
- Enhance communication, information-sharing, and scientific exchange leading to greater work-sharing and potential mutual reliance on regulatory assessments.
- Promote transparency and clarity of regulatory and procedural requirements.
- Enhance the development of human resources and competencies.
- Reduce regulatory burden without compromising the safety, efficacy, or quality of generic drug products.
International collaborative effort in the area of generic products
Slide 8 - Active participants
- Chinese Taipei
- CMDh (EU)
- South Africa
Slide 9 - Organisation
Slide 10 - Governance
- IGDRP consists of a Steering Committee and Working Groups
- Role of the Steering Committee:
- makes decisions on behalf of the IGDRP;
- provides strategic direction;
- identifies and prioritises challenges to be addressed and collaborative activities;
- determines the implementation process and monitors the work plan(s); and
- authorises resources in support of advancing the IGDRP's goals and objectives.
- The Steering Committee is made up of one representative from each participating member and one observer each from the World Health Organization (WHO) and the European Directorate for the Quality of Medicines (EDQM)
Slide 11 - Operating principles
- Consensus driven in terms of governance and administrative issues
- Participating regulators may "opt-out" from particular work plan activities
- Provides necessary operational flexibility given diversity in systems and capacities
- Activities will complement and not duplicate work undertaken in other international activities
Slide 12 - Overarching activities
- Two face-to-face meetings/year, chair of Steering Committee and host rotate with each meeting (chair becomes the co-chair of subsequent meeting)
- Work continued via teleconference between meetings
Slide 13 - Overarching activities
- Regulatory Gap Analysis (lead: ANVISA, Brazil)
- Comparison of review process and features - legislation, key regulatory guidelines, phases of the application process, timelines, user fees (lead: HSA, Singapore)
- IT platform/central repository (lead: Swissmedic, Switzerland)
- Information and Work Sharing models:
- Decentralised Procedure (DCP) pilot (launched July 2014)
- Centralised Procedure (CP) pilot (launched Jan. 2015)
- Sharing of EU assessment reports in "real time"
Slide 14 - Activities - Working groups
- Quality Working Group
- Establish frameworks and mechanisms for information sharing and work sharing
- Focus on ASMF/DMF
- Bioequivalence Working Group
- Survey and collate and publish information from each jurisdiction
- develop tools (e.g. assessment templates, guidance for assessors) to aid in assessment
- Focus on biowaivers
Slide 15 - The future
- Drivers to continue:
- New and emerging science, medicines and technologies;
- Globalisation of issues and production chains;
- Emerging public health threats and needs;
- Sustainability and appropriateness of regulatory systems and oversight;
- Need to support risk-based and science-based review functions;
- Interest and the need for international alignment and sharing of best practices;
- Governmental initiatives for regulatory convergence and cooperation;
- Need for modernised information sharing systems;
- Public demand for greater openness and transparency and availability of information to make informed decisions.
Slide 16 - The future (cont'd)
- Roadmap under development that will:
- make available a strategic vision to articulate and guide the collective efforts of IGDRP in terms of where we are going and how we are going to get there;
- provides overarching concepts for the strategic priorities, describes inter-dependencies, as well the key objectives that will facilitate an assessment of the success of meeting our common goals.
Slide 17 - The future (cont'd)
- Ongoing projects of Quality WG and Bioequivalence WG
- Ongoing Worksharing projects - DCP and CP Worksharing Pilot
- Next IGDRP Meeting: 17-20 October 2016, Mexico City, Mexico
- Contact: IGDRPSecretariat@tga.gov.au
- Website: www.igdrp.com
Slide 18 - Thinking globally, acting locally
- Internation Generic Drug Regulators Programme (IGDRP)
- International Conference of Drug Regulatory Authorities (ICDRA)
- International Coalition of Medicines Regulatory Authorities (ICMRA)
- International Pharmaceutical Regulators Forum (IPRF)
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Slide 19 - Thank you