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

Chapter: 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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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
  1. (non-exhaustive) Reliance on GMP inspections performed by any EU authority, common inspection procedures, common approach to training and qualifications of inspectors
  2. Rapid alert system for quality defects
  3. Joint Audit Program
 
 
Bilateral between individual countries and/or regions Ongoing teleconferences as the confidence-building phase is evolving
  1. Ongoing communication (e.g., Joint Sectoral Group meetings, exchange of annual maintenance reports, ad hoc MRA partners meeting)
  2. Similar, not identical approaches
 
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
  1. Joint inspections
  2. Reliance on inspections by other authorities
  3. Feedback
 
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
  1. Establishment of cooperation mechanisms that will make it possible to strengthen the steering role for other national regulatory authorities
  2. Cooperation actions for GMP are being conducted to strengthen capacity building of Central American and Caribbean regulatory authorities
 
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)
  1. Audits of national regulatory capabilities
  2. Cooperation mechanisms for inspections
  3. Recognition of regulatory capacity in inspections
 
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)
  1. International cooperation in the area of GMP
  2. Developing and promoting harmonized GMP standards and guidance documents
  3. Training GMP inspectors
  4. Assessing (and reassessing) GMP inspectorates
  5. Facilitating cooperation and networking and planning of inspection
 
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
  1. Training activities/seminars/dexpert circles
  2. Guidance documents for inspectorates and industry
  3. Harmonized inspections procedure
  4. Reports on audited inspectorates
 
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.
×
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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.
×
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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.
×
Page 121
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.
×
Page 122
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.
×
Page 123
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.
×
Page 124
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.
×
Page 125
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.
×
Page 126
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.
×
Page 127
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.
×
Page 128
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.
×
Page 129
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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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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