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Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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Appendix C: Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise
Pages 119-130

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From page 119...
... Appendix C Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise 119
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From page 120...
... Reliance-Focused Mutual recognition Legally binding treaty between May cover human and agreement two participating parties and veterinary products (MRA) exchange of GMP certificates based on equivalent GMP compliance program Association of Recognition of GMP inspection Medicinal products in finished Southeast Asian of manufacturers of medicinal dosage forms; excludes such Nations (ASEAN)
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From page 121...
... Joint Audit Program Bilateral between individual countries Ongoing 1. Ongoing communication and/or regions teleconferences (e.g., Joint Sectoral Group as the meetings, exchange of annual confidence- maintenance reports, ad hoc building phase MRA partners meeting)
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From page 122...
... Establishment of cooperation Some technical cooperation on Health Organization mechanisms that will make marketing authorization and (PAHO) /WHO it possible to strengthen the inspections Latin American steering role for other national Initiative regulatory authorities International inspections 2.
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From page 123...
... capacity in inspections EMA, FDA Initially monthly Joint inspections meetings, then ad hoc continued
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From page 124...
... 2. Developing and promoting included harmonized GMP standards and guidance documents Initially restricted to finished products; currently being 3.
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From page 125...
... , Iran Food and Drug Administration (IFDA) , Irish Health Products Regulatory Authority (HPRA)
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From page 126...
... 126 REGULATING MEDICINES IN A GLOBALIZED WORLD Initiative Objective Scope
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From page 127...
... , Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) , South African Health Products Regulatory Authority (SAHPRA)
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From page 128...
... These initiatives are closely related. EMA/FDA mutual reliance confidence building derived from EMA/FA Finished Products Program.
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From page 129...
... , State Service of Ukraine on Medicines and Drugs Control (SMDC) , United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA)
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Key Terms

  • health products
  • medicines agency
  • medicinal products
  • gmp inspections
  • products regulatory

  • national agency
  • participating authority
  • joint inspections
  • european medicines
  • medicines authority

  • drug control
  • devices agency
  • state institute
  • initially restricted
  • central authority

  • guidance documents
  • reliance confidence
  • products agency
  • regulatory authority
  • state agency

  • spanish agency
  • regulatory agency
  • european national
  • state medicines
  • national initiative

  • products european
  • medical products
  • veterinary products
  • european gmp
  • swiss agency


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