The Mutual Reliance Initiative: A New World for Pharmaceutical Inspections Dara A. Corrigan Acting Deputy Commissioner for Global Regulatory Operations and Policy Food and Drug Law Institute’s Annual Conference May 5, 2017
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The Mutual Reliance Initiative:A New World for Pharmaceutical
Inspections
Dara A. Corrigan Acting Deputy Commissioner for Global Regulatory
Operations and Policy
Food and Drug Law Institute’s Annual ConferenceMay 5, 2017
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FDA Registered Drug Facilities
6,877 FACILITIES 957 FACILITIES
UnitedStates
EuropeanUnion
India
China
453 FACILITIES
435 FACILITIES
2011
FDA Registered Drug Facilities 2016
2%
28%
66%
66%
UnitedStates
EuropeanUnion
India
China
3
4
0
50
100
150
200
250
300
350
400
2011 2012 2013 2014 2015 2016
European Union
China
India
Rest of the World
FDA Inspections Throughout the World
• FDA inspected 32% of the drug facilities in EU
• 5% of inspected facilities in EU led to an Official Action Indicatedclassification
FDA Inspections In The European Union
• In 2016, there were 1224drug facilities in EU
KEY= ~ 25 Drug Facilities
= Facilities inspected in 2016
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• FDA inspected 21% of the drug facilities in China
• 22% of inspected facilities in China led to an Official Action Indicatedclassification
FDA Inspections In China
• In 2016, there were 754drug facilities in China
KEY= ~ 25 Drug Facilities
= Facilities inspected in 2016
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• FDA inspected 23% of the drug facilities in India
• 14% of inspected facilitiesin India led to an Official Action Indicatedclassification
FDA Inspections In India
• In 2016, there were 722drug facilities in India
KEY= ~ 25 Drug Facilities
= Facilities inspected in 2016
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Negotiation of the U.S. – EU Mutual Recognition Agreement
• Exchanged and analyzed ideas
• Developed Capability Assessment Process
• Amended 1998 Agreement
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2017 Revision to Pharmaceutical Annex to the 1998 U.S./EU MRA
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Scope
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Includes a vast majority of drugs
Certain products will be reevaluated in the future, such as vaccines and veterinary products
Surveillance and, under certain conditions, pre‐approval inspections of marketed human drug facilities located within the US and EU
Major Deliverables
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12
KEY= Facilities inspected in 2016
= Theoretical coverage post‐MRA
Potential FDA Inspection Coverage
CHINA INDIA
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