Public Q & A: Moving from Confidence Building to Mutual Reliance

1. What did FDA and EMA announce about sharing inspection information?
   
   FDA and EMA developed a strategy to increase sharing of inspection results conducted in each others’ territories. FDA may rely upon that information when deciding where to deploy our inspection resources. FDA (and EMA) will continue to make independent decisions based on all appropriate information available.
   
   The strategy applies to GMP inspections of manufacturing sites in the U.S. and the European Economic Area (EEA) involving products for human and veterinary use.
    
2. Why are EMA and FDA doing this?
   
   A large number of inspections are carried out by FDA in the EEA and vice versa. Due to competing demands for resources at both FDA and EMA, and the shift of pharmaceutical manufacturing away from Europe and the U.S., leveraging resources is in the best interest of public health.
   
   FDA and EMA recognized the efficiencies to be gained by progressing beyond existing collaborative projects towards reliance on each others’ inspection outcomes.
   Not only will this enable better use of regulatory resources it will also provide some relief to manufacturers who direct substantial resources to host inspections.
   
   Working in close partnership with our foreign counterparts will help strengthen the product safety net around the world.
    
3. Does this mean that FDA will be doing fewer foreign inspections?
   
   No, FDA inspectional resources will be allocated to other parts of the foreign inventory where risk may be greater.
    
4. What may EMA and FDA do with the inspection information they receive?
   
   The information may be used for many purposes including routine regulatory surveillance and making risk-based decisions about the products that are overseen by FDA and EMA. The information may also inform each agency’s decision about whether to waive a pre-approval or pre-authorization inspection or defer a surveillance inspection based on risk factors and inspectional history.
    
5. Can companies apply for an exemption from an inspection being performed?
   
   There are no exemption application provisions in this enhanced inspection cooperation strategy. However, if EMA has recently conducted a GMP inspection of your facility, you may provide the EMA report to FDA for consideration. If your firm is named in an application or dossier submitted to both FDA and EMA, you may inform both agencies of the concurrent submissions.
    
6. What are previous GMP confidence-building activities that EMA and FDA have pursued?
   
   API Program

• Interim Report (published on the FDA website):
  Interim report on the International API inspection Pilot Programme
   
•  Final Report: (published on the FDA website):
  Final report on the International API inspection Pilot Programme
    

Finished Dosage (FD) Joint Inspection Pilot

• EMA General Principles and Terms of Reference (published on EMA’s website)