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

References

1. 1.↵
   1. Ferguson M.

   The Future of Pharmaceutical Manufacturing in the EU. Presented at the SSPC Seminar, Brussels, Belgium, February 28, 2017.
2. 2.↵
   European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures, Key data, 2019. EFPIA Web site. https://www.efpia.eu/media/412931/the-pharmaceutical-industry-in-figures-2019.pdf (accessed July 28, 2019).
3. 3.↵
   European Medicines Agency. EU and US Reach a Milestone in Mutual Recognition of Inspections of Medicines Manufacturers, 2019. EMA Web site. https://www.ema.europa.eu/en/documents/press-release/eu-us-reach-milestone-mutual-recognition-inspections-medicines-manufacturers_en.pdf (accessed October 20, 2019).
4. 4.↵
   U.S. Food and Drug Administration. Mutual Recognition Agreement (MRA). A New World for Pharmaceutical Inspections. FDA Web site. https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra (accessed September 29, 2019).
5. 5.↵
   European Medicines Agency. Overview of Specific MRAs. EMA Web site. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra#united-states-section (accessed April 19, 2020).
6. 6.↵
   Germany Joins U.S.–EU Inspection Partnership, 2019. FDAnews Web site. https://www.fdanews.com/articles/191923-germany-joins-us-eu-inspection-partnership (accessed September 29, 2019).
7. 7.↵
   U.S. Food and Drug Administration. Frequently Asked Questions—Mutual Recognition Agreement. FDA Web site. https://www.fda.gov/media/103391/download (accessed September 29, 2019).
8. 8.↵
   1. Abram A. K.,
   2. Abdoo M.

   Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators, 2019. FDA Web site. https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/ensuring-patient-safety-and-drug-manufacturing-quality-through-partnership-european-union-regulators (accessed September 30, 2019).
9. 9.↵
   European Medicines Agency. EU–US Mutual Recognition of Inspections of Medicines Manufacturers Enters Operational Phase, 2017. EMA Web site. https://www.ema.europa.eu/en/news/eu-us-mutual-recognition-inspections-medicines-manufacturers-enters-operational-phase (accessed September 30, 2019).
10. 10.↵
    Press Release: EU–U.S. Trade Talks: Milestone Reached in Mutual Recognition on Pharmaceuticals, 2019. European Commission Web site. https://ec.europa.eu/commission/presscorner/detail/en/IP_19_4090 (accessed September 29, 2019).
11. 11.↵
    U.S. Food and Drug Administration. Data Dashboard. Compliance Dashboards. Inspections. FDA Web site. https://datadashboard.fda.gov/ora/cd/inspections.htm (accessed March 10, 2019)
12. 12.↵
    European Medicines Agency. Eudra GMDP Database. Compliance with Good Manufacturing Practice. http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do (accessed January 20, 2019).
13. 13.↵
    European Commission. Mutual Recognition Agreements (MRA), 2017. http://trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155398.pdf (accessed October 18, 2019)
14. 14.↵
    A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers, 2013. EMA Web site. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-community-procedures-inspections-exchange-information_en.pdf (accessed March 29, 2020). 
15. 15.↵
    International Trade Centre UNCTAD/WTO. Trade Map—Trade Statistics for International Business Development. https://www.trademap.org/ (accessed May 8, 2019).
16. 16.↵
    1. Romer P. M.

    Endogenous Technological Change. J. Polit. Econ. 1990, 98 (5, Part 2), S71–S102.

    OpenUrlCrossRefWeb of Science
17. 17.↵
    1. Dalmazzo A.

    Technological Complexity, Wage Differentials and Unemployment. Scand. J. Econ. 2002, 104 (4), 515–530.

    OpenUrl
18. 18.↵
    1. Hidalgo C. A.,
    2. Hausmann R.

    The Building Blocks of Economic Complexity, Proc. Natl. Acad. Sci. U.S.A. 2009, 106 (26), 10570–10575.

    OpenUrlAbstract/FREE Full Text
19. 19.↵
    EvaluatePharma World Preview 2018, Outlook to 2024, 2018. Evaluate Web site. https://www.evaluate.com/thought-leadership/pharma/evaluatepharma-world-preview-2018-outlook-2024#download (accessed October 20, 2019).