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Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. 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 Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. 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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Page 100
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. 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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Page 101
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 102
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 103
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 104
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 105
Suggested Citation:"Appendix D: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2019. 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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Page 106

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Appendix D Study Approach and Methods The U.S. Food and Drug Administration (FDA) Office of International Programs 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. We 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 AND ONLINE 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 OECD, 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 including 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 mainly consisted 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, and the open session agendas for those sessions appear below. In addition to the committee meetings, fourteen information gathering sessions were held with key parties, through virtual teleconference 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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS D-1

APPENDIX D guiding questions, and concluded with a discussion between the participant(s) and committee members. Due to 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 is provided below. ADDITIONAL FEEDBACK As part of the fact-finding process, the committee and project staff compiled and sent four questions regarding information-sharing, work-sharing, recognition of other agency’s decisions, and recognition of regulatory standards, to the regulatory authorities of various countries. Dependent on the answers, each of the four questions opened up to ask supplemental questions in order to better understand the landscape of mutual recognition agreements (MRAs) and other reliance-based procedures in the regulation of medicines. The committee and project staff received and utilized four responses as supplemental reference materials to the 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, WHO and Senior Fellow Emeritus, MSH (virtual connection) 10:00 am THE VALUE OF MRAS: LEVERAGING EFFICIENCIES FOR GREATER PUBLIC HEALTH PROTECTION Dara Corrigan Fresenius Kabi/former FDA 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 PREPUBLICATION COPY: UNCORRECTED PROOFS D-2

APPENDIX D 3 1:00 pm EXPLORE GOALS AND QUESTIONS FOR 2nd OPEN SESSION OPEN SESSION - 2 1:30 pm RECONVENE Alastair Wood, Committee Chair 1:35 pm CURRENT MRA PERSPECTIVES FROM FDA Mary Ann Slack, FDA 2:20 pm FINANCIAL EFFICIENCES DERIVED FROM MEXICO’S MRAs Julio Sánchez y Tépoz, ALó ProSciences/former COFEPRIS, Mexico 3:00 pm THREE EXAMPLES OF MUTUAL RECOGNITION FROM THE BRAZILIAN PERSPECTIVE Dirceu Barbano, former Director-Chairman, ANVISA (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 10min remarks, followed by facilitated discussion PREPUBLICATION COPY: UNCORRECTED PROOFS D-3

APPENDIX D 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 (TGA), Australia Adrian Bootes Branch head, Prescription Medicines Authorisation Therapeutic Goods Administration (TGA), 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 and Healthcare Products Regulatory Agency (MHRA), UK Agnes Saint-Raymond and Brendan Cuddy Agnes Saint-Raymond Head of International Affairs Division European Medicines Agency (EMA) Brendan Cuddy Head of Manufacturing Quality and Supply Chain Integrity European Medicines Agency (EMA) Dominique De Backer Dominique De Backer, Policy Officer, Pharmaceutical Unit at DG Health and Food Safety PREPUBLICATION COPY: UNCORRECTED PROOFS D-4

APPENDIX D 5 European Commission (EC) John Lynch GMP Inspector and Senior Inspector Division Health Products Regulatory Authority (HPRA), Ireland 11:00 am Group Discussion 12:30 pm LUNCH SESSION II: STAKEHOLDER INPUT Input from stakeholder, 15 min 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 (IFPMA) Rebecca Lumsden Director – EM Regulatory Policy, Pfizer On behalf of IFPMA Facilitated discussion and questions from the committee 3:15 pm Patient Group Kawaldip Sehmi Chief Executive Officer International Alliance of Patients’ Organizations (IAPO) 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: UK, Medicines and Healthcare Products Regulatory Agency Participant(s): Ian Hudson, Chief Executive PREPUBLICATION COPY: UNCORRECTED PROOFS D-5

APPENDIX D Meeting 2 (Virtual): Date: May 7, 2019 Country/regulatory agency: EU, European Medicines Agency (EMA) Participant(s): Agnes Saint-Raymond, Head of International Affairs Division, Head of Portfolio Board; Tania Teixeira, EMA Liaison Official, U.S. FDA 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) (AEMPS) 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 (PIC/S) Participant(s): Anne Hayes, Deputy Chair; John Lynch, former member of the Committee of Officials of PIC/S Meeting 7 (Virtual): Date: June 10, 2019 PREPUBLICATION COPY: UNCORRECTED PROOFS D-6

APPENDIX D 7 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 (TGA) 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 (FDA) 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 (IGBA) Participant(s): Suzette Kox, Secretary General Meeting 12 (Virtual): Date: July 24, 2019 Country/regulatory agency: Singapore, Health Sciences Authority of Singapore (HSA) 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 PREPUBLICATION COPY: UNCORRECTED PROOFS D-7

APPENDIX D Country/regulatory association: United States, Association for Accessible Medicines (AAM) Participant(s): David R. Gaugh, Sr. 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 and Healthcare products Regulatory Agency (MHRA) Participant(s): Jonathan Mogford, Director of Policy PREPUBLICATION COPY: UNCORRECTED PROOFS D-8

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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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