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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Appendix D

Study Methods

The U.S. Food and Drug Administration’s (FDA’s) Office of International Programs (now the Office of Global Policy and Strategy) commissioned the National Academies of Sciences, Engineering, and Medicine to review and assess the current and potential use of mutual recognition agreements (MRAs) and other reliance-based procedures in the regulation of medicines. The National Academies assembled an expert committee to examine the ways these tools are being used, as well as the benefits, risks, and challenges associated with such arrangements.

LITERATURE SEARCH

An extensive search of the literature was conducted. The search parameters included publications after 2005 in English, Spanish, and French drawn from peer-reviewed journals, law reviews, and the grey literature. Databases searched included Embase, Lexis Law Reviews, Medline, PubMed, and Scopus. Organizational reviews were also conducted to include the Organisation for Economic Co-operation and Development (OECD), the World Trade Organization, and the World Health Organization. Primary search terms were Mutual Recognition Agreements, MRA, and Reliance. There were 40 secondary search terms grouped into four areas: functions, implementation, authorities, and individual nations. This search returned 110 articles.

Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

ONLINE SEARCHES

For the landscaping, more recent information not contained in the standard searches was required. Therefore, the literature search was supplemented with online searches that consisted mainly of searching governmental websites for documents and other reports.

MEETINGS AND INFORMATION-GATHERING SESSIONS

During the course of the year-long study, the committee held four in-person meetings (February, April, July, and September 2019). The April and July committee meetings included portions open to the public; the agendas for those open sessions appear below. In addition to the committee meetings, 14 information-gathering sessions were held with key parties through virtual teleconferences and in-person meetings.

Open meetings and information-gathering sessions were organized to facilitate direct conversation between committee members and the regulators of various countries. The overall objectives of the open meetings and information-gathering sessions were to gather input from a wide range of interested parties on their experience with and use of mutual recognition/reliance agreements and informal practices of recognition/reliance, which allow regulators to use information from their counterparts at foreign drug regulatory agencies, in medicines regulation.

All of the information-gathering sessions observed the same general format beginning with opening remarks from the committee chair, followed by remarks from the participant(s) based on guiding questions, and concluding with a discussion between the participant(s) and committee members. Given the varying international locations of the experts, most of these sessions were held through virtual teleconference software. The dates and participants for each information-gathering session are provided below.

ADDITIONAL FEEDBACK

As part of the fact-finding process, the committee and project staff compiled and distributed to the regulatory authorities of various countries a committee-developed supplemental information-gathering questionnaire consisting of four questions regarding information sharing, work sharing, recognition of other agencies’ decisions, and recognition of regulatory standards. Depending on the answers given to these questions, supplemental questions were posed to help the committee better understand the landscape of MRAs and other reliance-based procedures in the regulation of medicines. The committee and project staff received and utilized four sets of responses to supplement their other methods of information gathering.

Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

PUBLIC COMMITTEE MEETING AGENDAS

Open Meeting 1:

Date: April 1, 2019

Location: National Academy of Sciences

2101 Constitution Avenue, NW, Washington, DC 20418

OPEN SESSION 1

9:25 am OPENING REMARKS
Alastair Wood, Committee Chair
9:30 am MUTUAL RECOGNITION AND PUBLIC HEALTH: POTENTIAL BENEFITS AND CHALLENGES
Moderator: Alastair Wood
Jonathan “Jono”
Quick Former Director, Essential Medicines and Pharmaceutical Policies, World Health Organization, and Senior Fellow Emeritus, Management Sciences for Health (virtual connection)
10:00 am THE VALUE OF MRAs: LEVERAGING EFFICIENCIES FOR GREATER PUBLIC HEALTH PROTECTION
Dara Corrigan
Fresenius Kabi/formerly with U.S. Food and Drug Administration
11:00 am Break—Adjourn open session
11:15 am DEBRIEF 
12:00 pm WORKING LUNCH: PREPARE FOR OPEN SESSION 2
Lunch available in cafeteria, please return to meeting room for closed session discussion
1:00 pm EXPLORE GOALS AND QUESTIONS FOR OPEN SESSION 2 

OPEN SESSION 2

1:30 pm RECONVENE
Alastair Wood, Committee Chair
Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
1:35 pm CURRENT MRA PERSPECTIVES FROM FDA
Mary Ann Slack, U.S. Food and Drug Administration
2:20 pm FINANCIAL EFFICIENCES DERIVED FROM MEXICO’S MRAs
Julio Sánchez y Tépoz
ALó ProSciences/formerly with Federal Commission for the Protection against Sanitary Risks, Mexico
3:00 pm THREE EXAMPLES OF MUTUAL RECOGNITION FROM THE BRAZILIAN PERSPECTIVE
Dirceu Barbano
Former Director-Chairman, Brazilian Health Regulatory Agency (virtual connection)
3:30 pm Adjourn open session

Open Meeting 2:

Date: July 10, 2019

Location: Bill & Melinda Gates Foundation—London Office

62 Buckingham Gate, London SW1E 6AJ

8:30 am WELCOME
Mary Lou Valdez
Associate Commissioner for Diplomacy and Partnership
Office of Global Policy and Strategy
U.S. Food and Drug Administration
8:35 am OPENING REMARKS
Alastair Wood, Committee Chair
9:00 am SESSION I: INFORMATION EXCHANGE AND USE AND SCOPE OF EXCHANGED INFORMATION PRESENTATIONS WITH FACILIATATED DISCUSSIONS
National Regulatory Agencies 10-minute remarks, followed by facilitated discussion
REGULATORS—PART 1 
9:00 am Alison Cossar (virtual)
Manager, Pre-Market Medicine Group
Medsafe, Ministry of Health, New Zealand
Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
  Kaylene Raynes and Adrian Bootes (virtual)
Kaylene Raynes
Director, Applications & Advisory Management
Prescription Medicines Authorisation Branch, Therapeutic Goods Administration, Australia
Adrian Bootes
Branch head, Prescription Medicines Authorisation Therapeutic Goods Administration, Australia
Jörg Schläpfer and Federico Cimini
Jörg Schläpfer
Sector Management Services and International Affairs Swiss Agency for Therapeutic Products (Swissmedic)
Federico Cimini
Head of Division Inspectorates
Swiss Agency for Therapeutic Products (Swissmedic)
9:30 am Group Discussion 
10:00 am BREAK 
REGULATORS—PART 2 
10:20 am Siu Ping Lam
Director, Licensing Division
Medicines & Healthcare products Regulatory Agency, United Kingdom
Agnes Saint-Raymond and Brendan Cuddy
Agnes Saint-Raymond
Head of International Affairs Division
European Medicines Agency
Brendan Cuddy
Head of Manufacturing Quality and Supply Chain Integrity
European Medicines Agency
Dominique De Backer
Policy Officer, Pharmaceutical Unit at DG Health and Food Safety
European Commission
Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
  John Lynch
GMP Inspector and Senior Inspector
Health Products Regulatory Authority, Ireland
11:00 am Group Discussion 
12:30 pm LUNCH 
SESSION II: STAKEHOLDER INPUT
Input from stakeholder, 15-minute remarks, followed by facilitated discussion
1:30 pm International Organization (virtual)
Emer Cooke
Director, Regulation of Medicines and Other Health Technologies
World Health Organization
Facilitated discussion and questions from the committee 
2:30 pm Industry
Janis Bernat and Rebecca Lumsden
 
Janis Bernat
Director, Biotherapeutics and Scientific Affairs
International Federation of Pharmaceutical Manufacturers & Associations
Rebecca Lumsden
Director–EM Regulatory Policy, Pfizer
On behalf of International Federation of Pharmaceutical Manufacturers & Associations
Facilitated discussion and questions from the committee 
3:15 pm Patient Group
Kawaldip Sehmi
Chief Executive Officer
International Alliance of Patients’ Organizations
Facilitated discussion and questions from the committee 
4:00 pm Adjourn open session
Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

Information-Gathering Sessions

Meeting 1 (Virtual):

Date: May 3, 2019

Country/regulatory agency: United Kingdom, Medicines & Healthcare products Regulatory Agency

Participant(s): Ian Hudson, Chief Executive

Meeting 2 (Virtual):

Date: May 7, 2019

Country/regulatory agency: European Union, European Medicines Agency

Participant(s): Agnes Saint-Raymond, Head of International Affairs Division, Head of Portfolio Board; Tania Teixeira, European Medicines Agency Liaison Official, U.S. Food and Drug Administration

Meeting 3 (Virtual):

Date: May 28, 2019

Country/regulatory agency: Switzerland, Swissmedic

Participant(s): Petra Doerr, Head of Sector Communication and Networking; other Swissmedic staff members; Raimund T. Bruhin, Executive Director

Meeting 4 (Virtual):

Date: May 29, 2019

Country/regulatory agency: Spain, Agencia Española de Medicamentos y Productos Sanitarios (Spain’s Agency for Medicines and Health Products)

Participant(s): Belén Escribano, Head of Pharmaceutical Inspection and Enforcement Department; Manuel Ibarra Lorente, Head, Area of Inspection of Standards of GMP and GLP; R. San José Rodriguez, Department of Inspection and Control of Medicines; Jesús Díaz Hernández, Technical Advisor, Quality Unit and Secretariat Technical Inspection Committee, Department of Drug Inspection and Control

Meeting 5 (Virtual):

Date: May 31, 2019

Country/regulatory agency: Canada, Health Canada

Participant(s): Kimby Barton, Director, Health Products Inspection & Licensing (HPIL); Linsey Hollett, Acting Director General, Health Product Compliance Directorate (HPCD); Stephen McCaul, GMP Manager; Stéphanie Anctil, MRA Officer

Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

(HPIL); Louise Kane, Manager, MRA and International Affairs Program; Celina Bak, Acting Associate Director, Health Product Compliance and Risk Management (HPCRM); Ann Kourtesis, Acting GMP Manager–Foreign Sites; Joy Bregg, Acting GMP Manager–Domestic; Kim Dayman-Rutkus, Senior Policy Advisor, Policy and Regulatory Strategies Directorate

Meeting 6 (Virtual):

Date: June 6, 2019

Country/regulatory agency: Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme

Participant(s): Anne Hayes, Deputy Chair; John Lynch, former member of the Committee of Officials of Pharmaceutical Inspection Co-operation Scheme

Meeting 7 (Virtual):

Date: June 10, 2019

Country/regulatory agency: United States, Food and Drug Administration

Participant(s): Peter Marks, Director of the Center for Biologics Evaluation and Research

Meeting 8 (Virtual):

Date: June 10, 2019

Country/regulatory agency: United States, Food and Drug Administration

Participant(s): Janet Woodcock, Director of the Center for Drug Evaluation and Research

Meeting 9 (Virtual):

Date: June 10, 2019

Country/regulatory agency: Australia, Therapeutic Goods Administration

Participant(s): Kaylene Raynes, Director, Applications & Advisory Management; Jane Cook, First Assistant Secretary, Medicines Regulation Division, Prescription Medicines Authorisation; Adrian Bootes, Branch Head, Prescription Medicines Authorisation; Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division; Joe Hlubucek, Senior Policy Officer, International Regulatory Coordination Section

Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

Meeting 10 (In-person):

Date: June 11, 2019

Country/regulatory agency: United States, Food and Drug Administration

Participant(s): Mark Abdoo, Associate Commissioner of the Office of Global Policy and Strategy

Meeting 11 (Virtual):

Date: June 26, 2019

Country/regulatory agency: International Generic and Biosimilar Medicines Association

Participant(s): Suzette Kox, Secretary General

Meeting 12 (Virtual):

Date: July 24, 2019

Country/regulatory agency: Singapore, Health Sciences Authority

Participant(s): Chan Chen Leng, Group Director, Health Products Regulation Group (HPRG); Jessica Teo, Division Director, Audit and Licensing Branch, HPRG; Agnes Chan, Director, Therapeutic Products Branch, HPRG; Chua Siew Wei, Deputy Director, Stakeholder Engagement Office, HPRG

Meeting 13 (In-person):

Date: July 29, 2019

Country/regulatory association: United States, Association for Accessible Medicines

Participant(s): David R. Gaugh, Senior Vice President for Sciences and Regulatory Affairs; Lisa Parks, Vice President for Sciences and Regulatory Affairs

Meeting 14 (Virtual):

Date: August 2, 2019

Country/regulatory agency: Medicines & Healthcare products Regulatory Agency

Participant(s): Jonathan Mogford, Director of Policy

Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×

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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"Appendix D: Study Methods." National Academies of Sciences, Engineering, and Medicine. 2020. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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