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.
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.
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 |
| 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 |
| 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 |
| 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 |
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
(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
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
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