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

LÍgia Maria Gaspar Ernesto; Rui Miguel Dias Loureiro

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 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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vol. 74 no. 6 617-626

DOI

https://doi.org/10.5731/pdajpst.2020.011437

PubMed

32540862

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Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 10, 2020.

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previous version (June 15, 2020 - 07:19).
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LÍgia Maria Gaspar Ernesto* and
Rui Miguel Dias Loureiro

Faculdade de Farmácia, Universidade de Lisboa.

↵* 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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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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