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Research ArticleResearch

Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement

LÍgia Maria Gaspar Ernesto and Rui Miguel Dias Loureiro
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 617-626; DOI: https://doi.org/10.5731/pdajpst.2020.011437
LÍgia Maria Gaspar Ernesto
Faculdade de Farmácia, Universidade de Lisboa.
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  • For correspondence: ligiaernesto@gmail.com
Rui Miguel Dias Loureiro
Faculdade de Farmácia, Universidade de Lisboa.
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Article Information

vol. 74 no. 6 617-626
DOI 
https://doi.org/10.5731/pdajpst.2020.011437
PubMed 
32540862

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2020.

Article Versions

  • previous version (June 15, 2020 - 07:19).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. LÍgia Maria Gaspar Ernesto* and
  2. Rui Miguel Dias Loureiro
  1. Faculdade de Farmácia, Universidade de Lisboa.
  1. ↵* Corresponding Author: Lígia Maria Gaspar Ernesto, Faculdade de Farmácia da Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003, Lisboa, Portugal; E-mail: ligiaernesto{at}gmail.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
LÍgia Maria Gaspar Ernesto, Rui Miguel Dias Loureiro
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 617-626; DOI: 10.5731/pdajpst.2020.011437

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Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement
LÍgia Maria Gaspar Ernesto, Rui Miguel Dias Loureiro
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 617-626; DOI: 10.5731/pdajpst.2020.011437
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Keywords

  • European Union (EU)
  • United States (US) Food and Drug Administration (FDA)
  • Mutual recognition agreement (MRA)
  • Good manufacturing practice (GMP) inspections
  • Conventional manufacturing operations
  • Complex manufacturing operations
  • Exports
  • Competitiveness

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