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Globalization and FDA Compliance Trends
Letitia Robinson, PhD, RN/CAPT, USPHSCountry Director, India Office
Office of International Programs, US FDA4th Indian Pharmaceutical Forum 2019
February 27, 2019Mumbai, India
2
FDA Registered Drug Facilities 2011-2018
10%
25%
63%
51%
United
States
European
Union
India
China
3
Global Drug Manufacturing Supply Chain
Source: Tweet by FDA Commissioner Scott Gottlieb (@SGottliebFDA) dated Jan 29, 2019
4
Risk-Based Site Selection Model
Source : https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM619302.pdf
5
Inspectional Data 2013-2017
Source: Tweet by FDA Commissioner Scott Gottlieb (@SGottliebFDA) dated Jan 29, 2019
6
FY2017 Inspectional Outcomes
19%
33%
22%
39%
52%
61%58%
54%
29%
6%
20%
7%
0%
10%
20%
30%
40%
50%
60%
70%
China EU India US
NAI VAI OAIwww.fda.gov
7
CGMP Warning Letters
2
11
18
15
3
16
22
18
1110
17
10
6
17
22
25
0
5
10
15
20
25
30
2015 2016 2017 2018*
Calendar Year
U.S. China India Other
www.fda.govExcludes warning letters related to compounding.*As of September 30, 2018.
8
3
16
37
2116
10 12 1310
15
1
8
11
2
2
93
0
5
10
15
20
25
30
35
2016 2017 2018
Calendar Year
99-32
66-40
ChinaIndia OtherChinaIndia Other ChinaIndia Other
www.fda.gov
Import Alerts
9
Recent Initiatives
• Recognition of Voluntary Consensus Standards - 2019 – https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulato
ryInformation/Guidances/UCM631269.pdf
• Enhancing the Utility of the Orange Book – 2019– https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulato
ryInformation/Guidances/UCM630099.pdf
• Ensuring data integrity and compliance with CGMP – 2018
– https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
