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.
European Union comprises of: European Commission(EC). European Federation of Pharmaceutical Industries Associations (EFPIA).European Union also containmultiple agencies like European Medicines. Evaluation Agency (EMEA). Committee for Medicinal Products for Human Use (CHMP) of the EMEA. National Health Agencies.
FDA Drug approval process EU Drug approval process Preclinical studies Preclinical studies Manufacturing Manufacturing Non clinical Non clinical data dataInvestigational 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
Food drug administration European UnionInstitutional review board Ethics Committee IRB IRB approval EC EC approval required required EC’s are IRB registration appointed or required authorized by states
Food drug Administration European UnionNotification Prior notification is not usually Formal inspection doneProcess given unless specified by the by inspectorates of the related FDA center. local regions.Inspection All expenses are covered by All expenses are coveredexpense FDA. by MAA holder including the travel expenseNumber of Usually wok alone Commonly work in a teaminspectors of two or three membersRegulatory Classifications include: Classifications include:classification NAI- no action indicated Criticalof inspectorial VAI-voluntary action indicated Majorfindings. OAI- official action indicated Minor Others
FDA LEGAL AUTHORITY ACTIONS FOR EU LEGAL AUTHORITY ACTIONSSPONSORS, MONITORS, AND CROS1. Warning and untitled Letters. EU GCP inspections are conducted by2. Re-inspection. EU member state inspectors. The EMA3. Termination of exemption (IND, IDE). does not have a role of enforcement4. Refusal to approve or license. like the FDA. Any enforcement actions5. Withdrawal of approval (PMA, NDA). are the responsibility of the individual6. Determination of not substantial member states concerned and areequivalent or rescission of 510K for subject to each country’s local laws anddevices regulations.7. Implementation of the applicationintegrity policy.8. Initiation of Stock recovery.9. Seizure of test articles.10. injunction.11. Prosecution under the FFDCA andother federal statutes e.g. 18 USC 371
FDA EUList of all polies/SOP’s /work During the Prior toinstructions conduct of clinical trials inspection inspectionincluding AE reportingInvestigator meeting presentation, During the Prior toattendance log, investigator agenda inspection inspectionList of ongoing clinical trials of IMP from During the Prior toprevious GCP inspection or minimum of inspection inspectionlast 3 yearsInstructions provided to Investigator and During the Prior tomonitors inspection inspectionComplete study report and Table of During the Prior tocontents forTrial Master File (TMF) inspection inspection
Common regulatory objectives Eliminate Unjustified difference. Harmonization between FDA and EU.
Efforts : - Transparency in system - Global submissions - Uniform reporting obligations Adoption of new or improved technical research and development - Common technical document - Pharmacovigilance.