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

Chapter: Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise

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Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 93
Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 94
Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 95
Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 96
Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 97
Suggested Citation:"Appendix C: Table of Global GMP Reliance Initiatives Based on ICMRA's Mapping Exercise." 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 98

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Appendix C Table of Global GMP Reliance Initiatives Based on ICMRA’s Mapping Exercise PREPUBLICATION COPY: UNCORRECTED PROOFS C-1

Table of Global Reliance Initiatives Based on ICMRA’s Mapping Exercise Initiative Objective Scope Membership Frequency of Work products meetings I. Single Unified System 1. (non-exhaustive) Reliance on GMP inspections performed by any EU authority, common inspection Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, procedures, common EU A single European GMP inspections of the Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, approach to training and Inspection GMP inspection manufacturers of API and Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Multiple meetings qualifications of System system. finished dosage forms Slovakia, Slovenia, Spain, Sweden, United Kingdom, Norway, Iceland, inspectors Liechtenstein 2. Rapid alert system for quality defects 3. Joint Audit Program II. Reliance-Focused 1. Ongoing Legally binding treaty communication (e.g. between two On-going Joint Sectoral Group MRA participating parties teleconferences as meetings, exchange of Mutual and exchange of GMP May cover human and far as annual maintenance Bilateral between individual Countries and/or regions Recognition Certificates veterinary products the confidence reports, Ad Hoc MRA Agreement based on equivalent building phase is Partners meeting) GMP Compliance evolving Program. 2. Similar, not identical approaches Recognition of Good Medicinal products in finished Under this MRA, all ASEAN MRA Manufacturing dosage forms; excludes ASEAN Association Practice (GMP) products such as Member States shall of Southeast Inspection of biopharmaceuticals, Brunei, Cambodia, Indonesia, Laos, Malaysia, Burma (Myanmar), Philippines, accept and recognize the Asian Nations Not applicable manufacturers of radiopharmaceuticals, Singapore, Thailand, Vietnam GMP Certificates and/or Mutual medicinal products traditional medicines and inspection reports of a Recognition between 10 ASEAN investigational Listed Inspection Arrangement Member States. medicinal products Service. To foster cooperation Joint inspections of API and mutual 1. Joint inspections manufacturers located European Medicines Agency (EMA) confidence between outside the participating European Directorate of the Quality of Medicines and Healthcare (EDQM) EMA/FDA/TG participating 2. Reliance on regions Reliance on API European National Supervisory Authorities A API regulators through Monthly TCs inspections by other inspections by other The US Food and Drug Administration (FDA) Program better communication authorities authorities Extended Australian Therapeutic Goods Administration (TGA) and exchange of inspections on behalf of other World Health Organization (WHO) information on 3. Feedback countries inspection planning. EMA/FDA Allows some Under this MRA, all EU The strategy is applicable to Mutual inspections on each Member States shall GMP inspections related to reliance other’s’ territories to Not applicable Ad hoc meetings accept and recognize the manufacturing sites located Confidence be deferred or waived GMP Certificates and/or in USA and EEA involving building* completely based on a inspection reports, and PREPUBLICATION COPY: UNCORRECTED PROOFS C-2

APPENDIX C number of products for both human batch testing reports of considerations. and veterinary use the US and vice versa Initiative Objective Scope Membership Frequency of Work products meetings Listing of a country as having equivalent GMP inspection and Country listed as EU API listing API only Bilateral between EU and country requesting list Not applicable supervision equivalent standards to those in the EU. III. Cooperation-Focused 1. Establishment of cooperation mechanisms that will make possible to 1. Audits of national strengthen the regulatory capabilities steering role for Some technical cooperation 2 meetings annually other national on marketing authorisation (one at 2. Cooperation PAHO/WHO regulatory and inspections PAHO/Washington mechanisms for Latin authorities. Steering committee: Brazil, Argentina, Mexico, Cuba, Colombia and the other at one inspections American International inspections of the Steering Initiative 2. Cooperation Committee countries) 3. Recognition of Actions for GMP are Periodic audits of NRA regulatory capacity in being conducted to inspections strengthen capacity building of Central America and Caribbean Regulatory Authorities. The overall objective is to see whether The overall objective is to greater international see whether greater collaboration can EMA/FDA international collaboration European Medicines Agency (EMA) help to better Initially Monthly Finished can help to better distribute distribute inspection meetings, then ad Joint inspections Products inspection capacity, allowing The US Food and Drug Administration (FDA) capacity, allowing hoc program* more sites to be monitored more sites to be and reducing unnecessary monitored and duplication. reducing unnecessary duplication. PREPUBLICATION COPY: UNCORRECTED PROOFS C-3

Initiative Objective Scope Membership Frequency of Work products meetings 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, Taiwan Food and Drug Administration (TFDA), 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 1. International co- (EOF), Pharmacy and Poisons Board of Hong Kong (PPBHK), Hungarian National operation in the field Institute of Pharmacy and Nutrition (NIPN), Icelandic Medicines Agency (IMA), of GMP Indonesian National Agency for Drug and Food Control (NADFC), Iran Food and Drug Administration (IFDA), Irish Health Products Regulatory Authority (HPRA), 2. Developing and Initially restricted to Israeli Institute for Standardization and Control of Pharmaceuticals (ISCP), 1. Training promoting medicinal products for Italian Medicines Agency (AIFA), Japanese Ministry of Health, Labour and activities/Seminars/ harmonised GMP human use, now some Welfare (MHLW), Japanese Pharmaceuticals and Medical Devices Agency (PMDA) expert circles standards and veterinary authorities are (MHLW and PMDA count as one PIC/S Participating Authority), Korea (Republic Twice a year for the guidance documents included PIC/S of) Ministry of Food and Drug Safety (MFDS), Latvian State Agency of Medicine Committee of 2. Guidance documents Pharmaceutic (ZVA), Liechtenstein's Office of Healthcare (AG), Lithuanian State Medicines Officials for inspectorates and 3. Training GMP Initially restricted to FP, al Inspection Control Agency (SMCA), Malaysian National Pharmaceutical Regulatory Agency industry inspectors currently being extended to Co-operation (NPRA), Maltese Medicines Authority (MAM), Mexican Federal Commission for Once a year for APIs Scheme the Protection Against Sanitary Risks (COFEPRIS), Dutch Health Care seminar and experts 3. Harmonised 4. Assessing (and Inspectorate (IGZ), New Zealand's Medicines and Medical Devices Safety circles inspections procedure reassessing) GMP GDP added to mandate Authority (Medsafe), Norwegian Medicines Agency (NOMA), Polish Chief inspectorates Pharmaceutical Inspectorate (CPI), Portuguese National Authority of Medicines 4. Reports on audited New Expert Circle on PIC/S and Health Products, IP (INFARMED IP), Romanian National Agency for inspectorates 5. Facilitating co- GCP & GPV Medicines and Medical Devices (NAMMD), Singapore's Health Sciences Authority operation and (HSA), Slovak State Institute for Drug Control (SIDC), Slovenian Agency for networking and Medicinal Products and Medical Devices (JAZMP), South African Health Products planning of Regulatory Authority (SAHPRA), Spanish Agency of Medicines and Medical inspection 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), 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 and Healthcare Products Regulatory Agency (MHRA), United Kingdom's Veterinary Medicine Directorate (VMD), U.S. Food and Drug Administration (US FDA) Partner to PIC/SEDQM - European Directorate for the Quality of Medicines & HealthCare, EMA - European Medicines Abbreviations Disclaimer API – Active Pharmaceutical Ingredients PREPUBLICATION COPY: UNCORRECTED PROOFS C-4

APPENDIX C FP – Finished Products 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 *The initiatives VI and VII are closely related. VI derived from VII. relevant websites or directly with the relevant organisations. PREPUBLICATION COPY: UNCORRECTED PROOFS C-5

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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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