Cooperation between regulatory authorities is essential for managing the complex global drug supply chain. The EU and FDA signed a mutual recognition agreement on GMP inspections in 1998 to increase efficiency and oversight of drug manufacturing inspections. Starting in November 2017, the agreement fully took effect, allowing the EU and FDA to rely on each other's GMP inspections for drug manufacturers in initially 8 EU member states, reducing duplication of inspections. The agreement is aimed at strengthening inspections and oversight while allowing for a more practical management of resources.

1. Cooperation is the Indispensible
Strategy of Future
14 Jan 2018

2. Mutual

3. Mutual
Reliance

4. Mutual
Recognition
Reliance

5. Mutual
Recognition
Reliance

6. Mutual
Recognition
Reliance Agreement

7. Mutual
Recognition
Reliance Agreement
Understanding

8. GMP
Inspections and
fast expanding
Global Burden
due to complex
supply chain

9. Raw
materials
Process
Packaging
Distribution

10. Raw
materials
Process
Packaging
Distribution
Acrosstheglobe

11. Raw
materials
Process
Packaging
Distribution
Acrosstheglobe
Multiplesites

12. Raw
materials
Process
Packaging
Distribution
Acrosstheglobe
Multiplesites
Multiplesites

13. Raw
materials
Process
Packaging
Distribution
Acrosstheglobe
Multiplesites
Multiplesites
Acrosstheglobe

14. Pre-Approval
Inspections
[Post-
Approval
inspections
Compliance
Inspections
For cause
Inspections
Investigations

15. Complete
Inspections
Abbreviated
Inspections

16. Pure
Consistent
Zero Mix
Up
Drug
Batches
1 2 3
Batch after Batch
Within Batch
Time after Time

17. GMP Elements
Premises Equipment Personnel Materials
Documentation
Qualification &
Validation
Etc.

18. GMP Systems
Quality
System
Production
System
Lab
Control
System
Facilities &
Equipment
System
Materials
System
Packaging
&
Labeling
System

19. GMP System Indicators & Attributes
Complaints Recall
Investigations
& CAPA
Internal
Audits
Reviews
Change
Management
Supplier
Qualification
Risk
Management
Deviations
Master
Maintenance
Plan
Master
Validation
Plan
Master
Training Plan
Calibration

20. Best management
of knowledge
Fast information
exchange
Best management
of resources
Emerging burden &
response time

21. Mutual Recognition Benefits
More
Practical to
Oversee
Greater
Efficiency
Strengthening
Inspections

22. EU-FDA Mutual Recognition Agreement
on GMP Inspections
Started in 1998
Partial
operation
Rapid alert system
Operational on 01
Nov 2017 In Operation Initially 8 EU member states
recognized by FDA

23. 8 EU Member States
Austria Croatia France Italy
Malta Spain Sweden UK
EU-FDA Mutual Recognition Agreement
on GMP Inspections

24. No duplication of inspections by the
respective authorities from 01 Nov 2017
Confidence building exercise done by both authorities to
assess the capability, capacity and procedures in place to
conduct GMP inspections
EU-FDA Mutual Recognition Agreement
on GMP Inspections