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Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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References
Pages 97-104

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From page 97...
... PowerPoint presention at the July 10–11, 2019, meeting of the Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, London, UK. Correia de Brito, A., C
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From page 98...
... 2018b. Report on the international active pharmaceutical ingredient inspection programme 2011–2016.
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From page 99...
... 2018d. Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages.
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From page 100...
... 2017. Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency.
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From page 101...
... World Health Organization. https://www.who.int/medicines/technical_briefing/tbs/TBS2019_WHO_ RSS_Capacity_Building_GBT.pdf (accessed September 30, 2019)
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From page 102...
... 2019a. Focused stakeholders consultation on revised draft PIC/S GMP guide annex 2a (manufacture of advanced therapy medicinal products for human use)
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From page 103...
... 2017a. China policies to promote local production of pharmaceutical products and protect public health.
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From page 104...
... 2019e. Essential medicines and health products: Why we need strong regulatory systems to reach universal health coverage.
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Key Terms

  • mutual recognition
  • regulatory authorities
  • essential medicines
  • recognition agreements
  • clinical trials

  • laboratory practice
  • drug regulatory
  • medicines regulatory
  • national regulatory
  • pharmaceutical products

  • inspection program
  • medical products
  • european medicines
  • practice inspectors
  • press release

  • drug inspection
  • zika virus
  • medicines agency
  • foreign drug
  • international coalition

  • pan american
  • clinical practice
  • guide annex
  • laboratory accreditation
  • process quality

  • drug discovery
  • drug supplies
  • genome project
  • active pharmaceutical
  • australia canada


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