Globalization and FDA Compliance Trends...Globalization and FDA Compliance Trends Letitia Robinson,...
Transcript of Globalization and FDA Compliance Trends...Globalization and FDA Compliance Trends Letitia Robinson,...
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
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