Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Initiative | Objective | Scope |
|---|---|---|
| I. Single Unified System | ||
| European Union (EU) Inspection System | A single European GMP inspection system | GMP inspections of the manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms |
| II. Reliance-Focused | ||
| Mutual recognition agreement (MRA) | Legally binding treaty between two participating parties and exchange of GMP certificates based on equivalent GMP compliance program | May cover human and veterinary products |
| Association of Southeast Asian Nations (ASEAN) MRA | Recognition of GMP inspection of manufacturers of medicinal products among 10 ASEAN Member States | Medicinal products in finished dosage forms; excludes such products as biopharmaceuticals, radiopharmaceuticals, traditional medicines, and investigational medicinal products |
| European Medicines Agency (EMA)/U.S. Food and Drug Administration (FDA)/ Therapeutic Goods Administration (TGA) API program | To foster cooperation and mutual confidence among participating regulators through better communication and exchange of information on inspection planning | Joint inspections of API manufacturers located outside the participating regions; reliance on API inspections by other authorities; extended inspections on behalf of other countries |
| EMA/FDA mutual reliance confidence building* | Allows some inspections on each other’s territories to be deferred or waived completely based on a number of considerations | The strategy is applicable to GMP inspections related to manufacturing sites located in the United States and the European Economic Area involving products for both human and veterinary use |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Membership | Frequency of Meetings | Work Products |
|---|---|---|
| Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | Multiple meetings |
|
| Bilateral between individual countries and/or regions | Ongoing teleconferences as the confidence-building phase is evolving |
|
| Brunei, Cambodia, Indonesia, Laos, Malaysia, Burma (Myanmar), the Philippines, Singapore, Thailand, Vietnam | Not applicable | Under this MRA, all ASEAN Member States shall accept and recognize the GMP certificates and/or inspection reports of a listed inspection service |
| Australian Therapeutic Goods Administration (TGA), European Directorate of the Quality of Medicines and HealthCare (EDQM), European Medicines Agency (EMA), European National Supervisory Authorities, U.S. Food and Drug Administration (FDA), World Health Organization (WHO) | Monthly teleconferences |
|
| Not applicable | Ad hoc meetings | Under this MRA, all EU Member States shall accept and recognize the GMP certificates and/or inspection reports, and batch testing reports of the United States and vice versa |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Initiative | Objective | Scope |
|---|---|---|
| EU API listing | Listing of a country as having GMP inspection and supervision standards equivalent to those in the EU | APIs only |
| III. Cooperation-Focused | ||
| Pan American Health Organization (PAHO)/WHO Latin American Initiative |
|
Some technical cooperation on marketing authorization and inspections International inspections Periodic audits of NRA |
| EMA/FDA Finished Products program* | The overall objective is to see whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication | |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Membership | Frequency of Meetings | Work Products |
|---|---|---|
| Bilateral between EU and country requesting list | Not applicable | Country listed as equivalent |
| Steering committee: Argentina, Brazil, Colombia, Cuba, Mexico | Two meetings annually (one at PAHO/Washington and the other at one of the Steering Committee countries) |
|
| EMA, FDA | Initially monthly meetings, then ad hoc | Joint inspections |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Initiative | Objective | Scope |
|---|---|---|
| Pharmaceutical Inspection Cooperation Scheme (PIC/S) |
|
Initially restricted to medicinal products for human use; now some veterinary authorities are included Initially restricted to finished products; currently being extended to APIs Good distribution practice (GDP) added to mandate New Expert Circle on PIC/S good clinical practice (GCP) and good pharmacovigilance practice (GPvP) |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Membership | Frequency of Meetings | Work Products |
|---|---|---|
| Argentinian National Institute of Drugs (INAME), Australian Therapeutic Goods Administration (TGA), Austrian Medicines and Medical Devices Agency (AGES), Belgian Federal Agency for Medicines and Health Products (AFMPS-FAGG), Canadian Health Products and Food Branch Inspectorate (HPFBI)—Health Canada, Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Cypriot Pharmaceutical Services (CyPHS), Czech State Institute for Drug Control (SÚKL), Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM), Danish Health and Medicines Authority (DKMA), Estonian State Agency of Medicines (SAM), Finnish Medicines Agency (FIMEA), French National Agency for Medicines and Health Products Safety (ANSM), French Agency for Food, Environmental & Occupational Health Safety (ANSES), German Federal Ministry of Health (BMG), Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices (ZLG) (BMG and ZLG count as one PIC/S Participating Authority), Greek National Organisation for Medicines (EOF), Pharmacy and Poisons Board of Hong Kong (PPBHK), Hungarian National Institute of Pharmacy and Nutrition (NIPN), Icelandic Medicines Agency (IMA), Indonesian National Agency for Drug and Food Control (NADFC), Iran Food and Drug Administration (IFDA), Irish Health Products Regulatory Authority (HPRA), Israeli Institute for Standardization and Control of Pharmaceuticals (ISCP), Italian Medicines Agency (AIFA), Japanese Ministry of Health, Labour and Welfare (MHLW), Japanese Pharmaceuticals and Medical Devices | Twice per year for the Committee of Officials Once per year for seminar and experts circles |
|
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Initiative | Objective | Scope |
|---|---|---|
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Membership | Frequency of Meetings | Work Products |
|---|---|---|
| Agency (PMDA) (MHLW and PMDA count as one PIC/S Participating Authority), Korea (Republic of) Ministry of Food and Drug Safety (MFDS), Latvian State Agency of Medicine (ZVA), Liechtenstein’s Office of Healthcare (AG), Lithuanian State Medicines Control Agency (SMCA), Malaysian National Pharmaceutical Regulatory Agency (NPRA), Maltese Medicines Authority (MAM), Mexican Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Dutch Health Care Inspectorate (IGZ), New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe), Norwegian Medicines Agency (NOMA), Polish Chief Pharmaceutical Inspectorate (CPI), Portuguese National Authority of Medicines and Health Products, IP (INFARMED IP), Romanian National Agency for Medicines and Medical Devices (NAMMD), Singapore’s Health Sciences Authority (HSA), Slovak State Institute for Drug Control (SIDC), Slovenian Agency for Medicinal Products and Medical Devices (JAZMP), South African Health Products Regulatory Authority (SAHPRA), Spanish Agency of Medicines and Medical Devices (AEMPS) (The competence for GMP/GDP inspections in Spain is shared between the central authority, Spanish Agency for Medicines and Medical Devices [AEMPS], and the Spanish regional authorities, which count as one PIC/S Participating Authority. All Spanish Medicinal Authorities, which are listed on the AEMPS web site, are considered as PIC/S Participating Authorities and are represented in PIC/S by the AEMPS), Swedish Medical Products Agency (MPA), Swiss Agency for Therapeutic Products (Swissmedic), Taiwan Food and Drug Administration (TFDA), |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Initiative | Objective | Scope |
|---|---|---|
NOTES: The original table includes the following disclaimer: “The information on this table has been compiled by EMA according to the available information. As in certain cases it is difficult to have accurate or up-to-date information and there are continuous changes, EMA strongly recommends to check the information with the relevant websites or directly with the relevant organizations.”
*These initiatives are closely related. EMA/FDA mutual reliance confidence building derived from EMA/FA Finished Products Program.
SOURCE: Adapted from EMA, 2016.
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
| Membership | Frequency of Meetings | Work Products |
|---|---|---|
| Thai Food and Drug Administration (Thai FDA), Turkish Medicines and Medical Devices Agency (TMMDA), State Service of Ukraine on Medicines and Drugs Control (SMDC), United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA), United Kingdom’s Veterinary Medicine Directorate (VMD), U.S. Food and Drug Administration (FDA) Partner to PIC/S: European Directorate for the Quality of Medicines and HealthCare, EMA-European medicines |
Suggested Citation:"Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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 C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise." 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.
×
