This document compares the drug approval processes and regulatory authorities of the FDA and the European Union. It outlines that the FDA comprises three main centers for drugs, biologics, and medical devices, while the EU comprises the European Commission and European Medicines Evaluation Agency. Both systems require preclinical and clinical studies in multi-phases before approval or marketing authorization. The document also notes some differences in legal authority actions, inspection procedures, and objectives to harmonize regulations between the two regions.

1. Course: RGA 6210
Instructor: Dr. Michael Drues

2. 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.

3. European 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.

5. FDA Drug approval process EU Drug approval process
Preclinical studies Preclinical studies
Manufacturing Manufacturing
Non clinical Non clinical
data data
Investigational new drug application Clinical trial application
Phase I Phase II Phase III Phase I Phase II Phase III
New Drug Application Marketing Authorization Application
Phase IV Post marketing Phase IV Post marketing

6. Food drug administration European Union
Institutional review board Ethics Committee
IRB IRB approval
EC EC approval
required required
EC’s are
IRB registration appointed or
required authorized by
states

7. Food drug Administration European Union
Notification Prior notification is not usually Formal inspection done
Process given unless specified by the by inspectorates of the
related FDA center. local regions.
Inspection All expenses are covered by All expenses are covered
expense FDA. by MAA holder including
the travel expense
Number of Usually wok alone Commonly work in a team
inspectors of two or three members
Regulatory Classifications include: Classifications include:
classification NAI- no action indicated Critical
of inspectorial VAI-voluntary action indicated Major
findings. OAI- official action indicated Minor
Others

8. FDA LEGAL AUTHORITY ACTIONS FOR EU LEGAL AUTHORITY ACTIONS
SPONSORS, MONITORS, AND CROS
1. Warning and untitled Letters. EU GCP inspections are conducted by
2. Re-inspection. EU member state inspectors. The EMA
3. Termination of exemption (IND, IDE). does not have a role of enforcement
4. Refusal to approve or license. like the FDA. Any enforcement actions
5. Withdrawal of approval (PMA, NDA). are the responsibility of the individual
6. Determination of not substantial member states concerned and are
equivalent or rescission of 510K for subject to each country’s local laws and
devices regulations.
7. 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

9. FDA EU
List of all polies/SOP’s /work During the Prior to
instructions conduct of clinical trials inspection inspection
including AE reporting
Investigator meeting presentation, During the Prior to
attendance log, investigator agenda inspection inspection
List of ongoing clinical trials of IMP from During the Prior to
previous GCP inspection or minimum of inspection inspection
last 3 years
Instructions provided to Investigator and During the Prior to
monitors inspection inspection
Complete study report and Table of During the Prior to
contents forTrial Master File (TMF) inspection inspection

10.  Common regulatory objectives
 Eliminate Unjustified difference.
 Harmonization between FDA and EU.

11.  Efforts :
- Transparency in system
- Global submissions
- Uniform reporting obligations
 Adoption of new or improved
technical research and development
- Common technical document
- Pharmacovigilance.

13. Thank You for Your Attention