National Academies Press: OpenBook

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators (2019)

Chapter: Appendix B: Table of Mutual Recognition Agreements

« Previous: Appendix A: Glossary
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 85
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 86
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 87
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 88
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 89
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 90
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 91
Suggested Citation:"Appendix B: Table of Mutual Recognition Agreements." 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 92

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 B Table of Mutual Recognition Agreements PREPUBLICATION COPY: UNCORRECTED PROOFS B-1

Mutual Agreements in the Regulation of Medicines Country Partners Operational Date Process Products Australia Canada January 1, 2006 GMP inspections and Therapeutic goods, including active pharmaceutical batch certification ingredients. European July 1, 2000 GMP inspections and The definition of medicinal products includes all Economic Area batch certification human and veterinary products, such as chemical and (Iceland, Norway, biological pharmaceuticals, immunologicals, Liechtenstein) radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre- mixed for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products. EU January 1, 1999, June GMP inspections and Human chemical pharmaceuticals; medicinal gases; 2001 for veterinary batch certification human biologicals, including vaccines, immunologicals medicines and biotherapeutics; human radiopharmaceuticals; stable medicinal products derived from human blood or human plasma; homeopathic medicines, if classified as medicinal product; vitamins, minerals and herbal medicines if classified as medicinal products; products intended for use in clinical trials, investigational medicinal products (IMPs), 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 preparation of veterinary medicated feedstuff; veterinary immunologicals, including vaccines, immunologicals and biotherapeutics. PREPUBLICATION COPY: UNCORRECTED PROOFS B-2

APPENDIX B New Zealand January 1, 1997 Product standards; Therapeutic goods manufacturing standards; conformance assessment requirements; and packaging and labelling standards Singapore July 1, 2001 GMP inspections and Medicinal products batch certification Canada European November 2002 GMP inspections and The list of products covered, as written in the Economic Area batch certification Agreement, is given below: (Iceland, Norway, human pharmaceuticals including prescription and non- Liechtenstein) prescription 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 non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds; where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products; and active pharmaceutical ingredients or bulk pharmaceuticals (Note: APIs are not GMP regulated). Clarifications: manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence); natural health products (Note: currently, certificates of compliance are provided by MRA partners. In Canada, regulatory amendments are being prepared that will PREPUBLICATION COPY: UNCORRECTED PROOFS B-3

allow Canadian NHP companies to hold an establishment licence in addition to the site licence 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 out under Section C.04.015 of the Food and Drug Regulations). Temporary exclusions: stable medicinal products derived from human blood or human plasma; and active pharmaceutical ingredients or bulk pharmaceuticals. Definite exclusions: blood and blood components; and veterinary biologics. EU February 2003 GMP inspections and The list of products covered, as written in the batch certification Agreement, is given below: human pharmaceuticals including prescription and non- prescription 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 non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds; where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products; and active pharmaceutical ingredients or bulk pharmaceuticals (Note: APIs are not GMP regulated). Clarifications: manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence); natural health products (NHP) (Note: currently, PREPUBLICATION COPY: UNCORRECTED PROOFS B-4

APPENDIX B 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 licence in addition to the site licence required under the Natural Health Products Regulations); pre-authorization / pre-marketing GMP inspections (Note: as of October 1st 2004, the Pre- Authorization / Pre-Marketing GMP Inspections are included under the scope of the MRA); 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 out under Section C.04.015 of the Food and Drug Regulations). Temporary exclusions: stable medicinal products derived from human blood or human plasma; and active pharmaceutical ingredients or bulk pharmaceuticals. Definite exclusions: blood and blood components; and veterinary biologics. Switzerland June 2000 GMP inspections, GLP, The list of products covered, as written in the and batch certification Agreement, is given below: human pharmaceuticals including prescription and non- prescription 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 non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds; where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products; and active pharmaceutical ingredients or bulk PREPUBLICATION COPY: UNCORRECTED PROOFS B-5

pharmaceuticals (Note: APIs are not GMP regulated). Clarifications: manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence); natural health products (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 licence in addition to the site licence 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 out under Section C.04.015 of the Food and Drug Regulations). Temporary exclusions: stable medicinal products derived from human blood or human plasma; and active pharmaceutical ingredients or bulk pharmaceuticals. Definite exclusions: blood and blood components; and veterinary biologics. EEA Switzerland June 1, 2002 GMP inspections, GLP, The definition of drugs includes all products for human and batch certification 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, minerals, medicinal herbs and homeopathic medicines. PREPUBLICATION COPY: UNCORRECTED PROOFS B-6

APPENDIX B EU Israel January 2013 The MRA with Israel is human chemical and biological pharmaceuticals; an agreement on human immunologicals; radiopharmaceuticals; conformity assessment vitamins, minerals and herbal medicines if classified as and acceptance of medicinal products; intermediate products and bulk industrial products pharmaceuticals; active pharmaceutical ingredients; (ACAA) excipients; veterinary chemical pharmaceuticals; premixes and preparation of veterinary medicated feedstuff; veterinary biologicals except immunologicals. Israel and the EU recognise official batch releases carried out by each other's authorities. Japan May 29, 2004, with GMP inspections, GLP, Original scope (subsequently amended in 2018): limited scope, updated and batch certification human medicines only, including: chemical scope July 2018 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 in the both parties; biological pharmaceuticals, including immunologicals and vaccines, that are: produced by cell culture utilising natural or recombinant microorganisms or established cell lines; derived from non-transgenic plants and non- transgenic animals; active pharmaceutical ingredients of any medicine covered in the agreement; sterile medicines that belong to any of the above categories. New Zealand January 1, 1999, for GMP inspections and Human chemical pharmaceuticals; medicinal gases; human medicines; batch certification human biologicals, including vaccines, immunologicals June 1, 2001, for and biotherapeutics; human radiopharmaceuticals; veterinary medicines. stable medicinal products derived from human blood or human plasma; homeopathic medicines, if classified as medicinal product; vitamins, minerals and herbal medicines if classified as medicinal products; products intended for use in clinical trials, investigational medicinal products (IMPs); intermediate products and bulk pharmaceuticals; veterinary chemical pharmaceuticals; premixes for preparation of veterinary medicated feedstuff; veterinary immunologicals, PREPUBLICATION COPY: UNCORRECTED PROOFS B-7

including vaccines, immunologicals and biotherapeutics. Switzerland June 2002 GMP inspections, GLP, Human chemical pharmaceuticals; medicinal gases; and batch certification 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 product; vitamins, minerals and herbal medicines if classified as medicinal products; products intended for use in clinical trials (investigational medicinal products - IMPs); active pharmaceutical ingredients; intermediate products and bulk pharmaceuticals; veterinary chemical pharmaceuticals; premixes for preparation of veterinary medicated feedstuff; veterinary immunologicals, including vaccines, immunologicals and biotherapeutics. Switzerland and the EU recognise official batch releases carried out by each other's authorities. US Entered into force on GMP inspections and Human chemical pharmaceuticals; medicinal gases; December 1, 1998, batch certification human biologicals, including immunologicals and but was in transition biotherapeutics; human radiopharmaceuticals; phase until July 2019 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 FDA recognizes all EU Member States PREPUBLICATION COPY: UNCORRECTED PROOFS B-8

Next: Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise »
Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators Get This Book
×
Buy Prepub | $59.00 Buy Paperback | $50.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!