National Academies Press: OpenBook

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators (2020)

Chapter: Appendix B: Table of Mutual Recognition Agreements

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Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Mutual Recognition Agreements (MRAs) in the Regulation of Medicines
Country Partners Operational Date Process Products
Australia Canada January 1, 2006 GMP inspections and batch certification Therapeutic goods, including active pharmaceutical ingredients.
  European Economic Area (Iceland, Norway, Liechtenstein) July 1, 2000 GMP inspections and batch certification The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals; immunologicals; radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; premixes for the preparation of veterinary medicated feedstuffs; and, where appropriate, vitamins, minerals, herbal remedies, and homeopathic medicinal products.
  European Union (EU) January 1, 1999; June 2001 for veterinary medicines GMP inspections and batch certification Human chemical pharmaceuticals; medicinal gases; human biologicals, including vaccines, immunologicals, and biotherapeutics; human radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; homeopathic medicines, if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; products intended for use in clinical trials, investigational medicinal products, except those used in phase I clinical trials; intermediate products and bulk pharmaceuticals; active pharmaceutical ingredients, only for human medicinal products; veterinary chemical pharmaceuticals; premixes for the preparation of veterinary medicated feedstuffs; veterinary immunologicals, including vaccines, immunologicals, and biotherapeutics.
  New Zealand January 1, 1997 Product standards, manufacturing standards; conformance assessment requirements, packaging and labeling standards Therapeutic goods
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
/table>
  Singapore July 1, 2001 GMP inspections and Medicinal products
Canada European Economic Area (Iceland, Norway, Liechtenstein) November 2002 atc cert cat on GMP inspections and batch certification Human pharmaceuticals including prescription and nonprescription drugs and medicinal gases; human biologicals including vaccines, stable medicinal products derived from human blood or human plasma, biotherapeutics, and immunologicals; human radiopharmaceuticals; veterinary pharmaceuticals, including prescription and nonprescription drugs, and premixes for the preparation of veterinary medicated feedstuffs; where appropriate, vitamins, minerals, herbal remedies, and homeopathic medicinal products; active pharmaceutical ingredients or bulk pharmaceuticals. (Note: Active pharmaceutical ingredients are not GMP regulated.)

Clarifications:
Manufactured drugs used in clinical trials (Note: Currently limited to sites already holding a manufacturing authorization/establishment license); natural health products (NHPs) (Note: Currently, certificates of compliance are provided by MRA partners. In Canada, regulatory amendments are being prepared that will allow Canadian NHP companies to hold an establishment license in addition to the site license required under the NHP regulations); and human biologicals. (Note: The MRA covers GMP evidence for manufacturing sites of human biologicals. It does not address the Canadian requirements for lot-to-lot release of these products as set forth under Section C.04.015 of the Food and Drug Regulations.)

Temporary exclusions:
Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals.

Definite exclusions: Blood and blood components; veterinary biologics.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
  EU February 2003 GMP inspections and batch certification Human pharmaceuticals including prescription and nonprescription drugs and medicinal gases; human biologicals including vaccines, stable medicinal products derived from human blood or human plasma, biotherapeutics, and immunologicals; human radiopharmaceuticals; veterinary pharmaceuticals, including prescription and nonprescription drugs, and premixes for the preparation of veterinary medicated feedstuffs; where appropriate, vitamins, minerals, herbal remedies, and homeopathic medicinal products; active pharmaceutical ingredients or bulk pharmaceuticals. (Note: Active pharmaceutical ingredients are not GMP regulated.)

Clarifications:
Manufactured drugs used in clinical trials (Note: Currently limited to sites already holding a manufacturing authorization/establishment license); NHPs (Note: Currently, certificates of compliance are provided by MRA partners. In Canada, regulatory amendments are being prepared that will allow Canadian NHP companies to hold an establishment license in addition to the site license required under the NHP regulations); pre-authorization/pre-marketing GMP inspections (Note: As of October 1, 2004, the pre-authorization/pre-marketing GMP inspections are included within the scope of the MRA); human biologicals. (Note: The MRA covers GMP evidence for manufacturing sites of human biologicals. It does not address the Canadian requirements for lotto-lot release of these products as set forth under Section C.04.015 of the Food and Drug Regulations.)

Temporary exclusions:
Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals.

Definite exclusions:
Blood and blood components; veterinary biologics.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
        Temporary exclusions:
Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals.

Definite exclusions:
Blood and blood components; veterinary biologics.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Mutual Recognition Agreements (MRAs) in the Regulation of Medicines
Country Partners Operational Date Process Products
  Switzerland June 2000 GMP inspections, GLP, and batch certification Human pharmaceuticals including prescription and nonprescription drugs and medicinal gases; human biologicals including vaccines, stable medicinal products derived from human blood or human plasma, biotherapeutics, and immunologicals; human radiopharmaceuticals; veterinary pharmaceuticals, including prescription and nonprescription drugs and premixes for the preparation of veterinary medicated feedstuffs; where appropriate, vitamins, minerals, herbal remedies, and homeopathic medicinal products; active pharmaceutical ingredients or bulk pharmaceuticals. (Note: Active pharmaceutical ingredients are not GMP regulated.)

Clarifications:
Manufactured drugs used in clinical trials (Note: Currently limited to sites already holding a manufacturing authorization/establishment license); NHPs (Note: Currently, certificates of compliance are provided by MRA partners. In Canada, regulatory amendments are being prepared that will allow Canadian NHP companies to hold an establishment license in addition to the site license required under the NHP regulations); human biologicals. (Note: The MRA covers GMP evidence for manufacturing sites of human biologicals. It does not address the Canadian requirements for lot-to-lot release of these products as set forth under Section C.04.015 of the Food and Drug Regulations.)

Temporary exclusions:
Stable medicinal products derived from human blood or human plasma; active pharmaceutical ingredients or bulk pharmaceuticals.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
        Definite exclusions:
Blood and blood components; and veterinary biologics.
EEA Switzerland June 1, 2002 GMP inspections, GLP, and batch certification Blood and blood components; and veterinary biologics. The definition of drugs encompasses all products for human and veterinary use, including chemical and biological pharmaceutical, immunological, and radiopharmaceutical products; stable drugs derived from blood and human plasma; premixes for the manufacture of medicated feed; and, where appropriate, vitamins,
EU Israel*  January 2013 The MRA with Israel is an agreement on conformity assessment and acceptance of industrial products Human chemical and biological pharmaceuticals; human immunologicals; radiopharmaceuticals; vitamins, minerals, and herbal medicines if classified as medicinal products; intermediate products and bulk pharmaceuticals; active pharmaceutical ingredients; excipients; veterinary chemical pharmaceuticals; premixes and preparation of veterinary medicated feedstuffs; veterinary biologicals except immunologicals. Israel and the EU recognize official batch releases carried out by each other’s authorities.
  Japan May 29, 2004, with limited scope, updated scope July 2018 GMP inspections, GLP, and batch certification Original scope (subsequently amended in 2018): human medicines only, including chemical pharmaceuticals; homeopathic medicinal products if classified as medicinal products and subject to GMP requirements in Japan; vitamins, minerals, and herbal medicines if classified as medicines by both parties; biological pharmaceuticals, including immunologicals and vaccines, that are produced by cell culture utilizing natural or recombinant microorganisms or established cell lines or derived from nontransgenic plants and nontransgenic animals; active pharmaceutical ingredients of any medicine covered in the agreement; sterile medicines that belong to any of the above categories.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Mutual Recognition Agreements (MRAs) in the Regulation of Medicines
Country Partners Operational Date Process Products
  New Zealand January 1, 1999, for human medicines; June 1, 2001, for veterinary medicines GMP inspections and batch certification Human chemical pharmaceuticals; medicinal gases; human biologicals, including vaccines, immunologicals, and biotherapeutics; human radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; homeopathic medicines if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; products intended for use in clinical trials; IMPs; intermediate products and bulk pharmaceuticals; veterinary chemical pharmaceuticals; premixes for preparation of veterinary medicated feedstuffs; veterinary immunologicals, including vaccines, immunologicals, and biotherapeutics.
  Switzerland June 2002 GMP inspections, GLP, and batch certification Human chemical pharmaceuticals; medicinal gases; human biologicals, including vaccines, immunologicals, and biotherapeutics; human radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; advanced-therapy medicinal products; homeopathic medicines if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; products intended for use in clinical trials (IMPs); active pharmaceutical ingredients; intermediate products and bulk pharmaceuticals; veterinary chemical pharmaceuticals; premixes for preparation of veterinary medicated feedstuffs; veterinary immunologicals, including vaccines, immunologicals, and biotherapeutics. Switzerland and the EU recognize official batch releases carried out by each other’s authorities.
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
  United States Entered into force on December 1, 1998, but was in transition phase until July 2019 GMP inspections and batch certification Human chemical pharmaceuticals; medicinal gases; human biologicals, including immunologicals and biotherapeutics; human radiopharmaceuticals; homeopathic medicines if classified as medicinal products; vitamins, minerals, and herbal medicines if classified as medicinal products; active pharmaceutical ingredients; intermediate products and bulk pharmaceuticals. Acceptance of batch testing certificates postponed until the U.S. Food and Drug Administration recognizes all EU Member States.

NOTES: EEA = European Economic Area; EU = European Union; GLP = good laboratory practice; GMP = good manufacturing practice; IMP = investigational medicinal product; NHP = natural health product.

*“Israel adopted the relevant legislation amendments in the field of pharmaceuticals, which ensured the application of European GMP requirements” (Aronov et al., 2019, p. 594).

Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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.
×
Page 113
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 B: Table of Mutual Recognition Agreements." 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.
×
Page 115
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Page 116
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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.
×
Page 117
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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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Next: Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise »
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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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