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