mini tutorial presentation
DESCRIPTION
The main purpose of this presentation is to investigate and differentiate the working of FDA and EU.TRANSCRIPT
Umesh SoniPrepared By:
Course: RGA 6210Instructor: Dr. Michael
Drues
Food Drug Administration
V/S European Union
FDA comprises of three main departments: Center for Drug Evaluation and
Research (CDER) for Drugs. Center for Biologics Evaluation
and Research (CBER) for Biologics
Center for Drug Evaluation and Research (CDRH) for Medical Devices.
Food Drug Administration
European UnionEuropean Union comprises of: European Commission(EC). European Federation of
Pharmaceutical Industries Associations (EFPIA).
European Union also contain multiple agencies like European Medicines. Evaluation Agency (EMEA). Committee for Medicinal
Products for Human Use (CHMP) of the EMEA.
National Health Agencies.
Differences in Food Drug Administration and
European Union
FDA Drug approval process EU Drug approval process
Differences in Approval Process
New Drug Application
Phase IV Post marketing
Investigational new drug applicationPhase I Phase II Phase III
Preclinical studiesNon clinical Manufacturing
data
Marketing Authorization Application
Phase IV Post marketing
Clinical trial applicationPhase I Phase II Phase III
Preclinical studiesNon clinical Manufacturing
data
Food drug administration European Union
Differences in Review Board
IRB approval required
IRB registration required
IRBEC approval required
EC’s are appointed or authorized by states
EC
Institutional review board Ethics Committee
Food drug Administration European Union
Notification Process
Prior notification is not usually given unless specified by the related FDA center.
Formal inspection done by inspectorates of the local regions.
Inspection expense
All expenses are covered by FDA.
All expenses are covered by MAA holder including the travel expense
Number of inspectors
Usually wok alone Commonly work in a team of two or three members
Regulatory classification of inspectorial findings.
Classifications include:NAI- no action indicatedVAI-voluntary action indicatedOAI- official action indicated
Classifications include:CriticalMajor MinorOthers
Differences in Inspection
Differences in Legal AuthorizationFDA LEGAL AUTHORITY ACTIONS FOR SPONSORS, MONITORS, AND CROS
EU LEGAL AUTHORITY ACTIONS
1. Warning and untitled Letters.2. Re-inspection.3. Termination of exemption (IND, IDE).4. Refusal to approve or license.5. Withdrawal of approval (PMA, NDA).6. Determination of not substantial equivalent or rescission of 510K for devices7. Implementation of the application integrity policy.8. Initiation of Stock recovery.9. Seizure of test articles.10. injunction. 11. Prosecution under the FFDCA and other federal statutes e.g. 18 USC 371
EU GCP inspections are conducted by EU member state inspectors. The EMA does not have a role of enforcement like the FDA. Any enforcement actions are the responsibility of the individual member states concerned and are subject to each country’s local laws and regulations.
FDA EUList of all polies/SOP’s /work instructions conduct of clinical trials including AE reporting
During the inspection
Prior to inspection
Investigator meeting presentation, attendance log, investigator agenda
During the inspection
Prior to inspection
List of ongoing clinical trials of IMP from previous GCP inspection or minimum of last 3 years
During the inspection
Prior to inspection
Instructions provided to Investigator and monitors
During the inspection
Prior to inspection
Complete study report and Table of contents forTrial Master File (TMF)
During the inspection
Prior to inspection
Differences in Document Request
Conclusion Common regulatory objectives
Eliminate Unjustified difference.
Harmonization between FDA and EU.
Conclusion
Efforts : - Transparency in system - Global submissions - Uniform reporting obligations
Adoption of new or improved technical research and development - Common technical document - Pharmacovigilance.
Questions and Answer
Thank You for Your Attention