US and EU Submission :      ComparativeGirish Swami,   (M.Pharm, PGDIPR, PGDDRA)                International Regulatory A...
Regulatory Agencies    United States f A    U it d St t of America:                       i         United States Food and...
US and EUROPE - FILINGUSA     Center for Drug evaluation and research (CDER)       New Drug Application (NDA)       Abbrev...
Overview of the USFDAGirish Swami, M.Pharm, PGDIPR, PGDDRA   Page 4 of 30
Regulatory Submission in USA        Dossier is submitted in eCTD format        Submission to Center for Drug Evaluation an...
NDA / ANDAGirish Swami, M.Pharm, PGDIPR, PGDDRA   Page 6 of 30
NDA / ANDA ContentGirish Swami, M.Pharm, PGDIPR, PGDDRA   Page 7 of 30
NDA / ANDA Content                    (cont.)Girish Swami, M.Pharm, PGDIPR, PGDDRA             Page 8 of 30
Regulatory Submission in Europe        EU submission process             b i i             National Process (NP)          ...
National Process (NP)        Individual applications to each country within the EU                                        ...
Decentralized Process (DCP)        Simultaneous authorization in numerous        countries in the EU.        More efficien...
Mutual Recognition process (MRP)        Review by one country and other countries        accept the decision.            p...
Centralized Process (CP)        One application applies to all countries in the EU                                        ...
Comparison of drug p             p             g product         dossier submission process                  in US & EUGir...
In EU : EMEA have administrative framework        where National agencies act as scientific                        g      ...
Registration process                                USGirish Swami, M.Pharm, PGDIPR, PGDDRA         Page 16 of 30
Registration process                                EUGirish Swami, M.Pharm, PGDIPR, PGDDRA         Page 17 of 30
Post approval changes                          US Vs EUGirish Swami, M.Pharm, PGDIPR, PGDDRA       Page 18 of 30
Post approval changes (US)Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 19 of 30
Post approval changes (EU)Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 20 of 30
Administrative        Requirement                           US               EU  Application                      ANDA    ...
Manufacturing And Control          Requirement                            US             EU  No.of batches                ...
Finished Product Control         Requirement                        US                    EU  Assay                       ...
Labeling Requirement        Requirement                        US                           EU  NDC No.                   ...
Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 25 of 30
Stability Requirement  Requirement                               US                      EU  No.of batches                ...
Bioequivalence Requirement      OGD: Office of Generic DrugsGirish Swami, M.Pharm, PGDIPR, PGDDRA   Page 27 of 30
US & EU                             Facility AuditGirish Swami, M.Pharm, PGDIPR, PGDDRA         Page 28 of 30
Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 29 of 30
Thank                              Th k youGirish Swami, M.Pharm, PGDIPR, PGDDRA    Page 30 of 30
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US and EU Submission – Comparative

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Comparison between USFDA and EU Regulatory Submission Process, NDA / ANDA and MAA

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  1. 1. US and EU Submission : ComparativeGirish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  2. 2. Regulatory Agencies United States f A U it d St t of America: i United States Food and Drug Administration (USFDA) Center for Drug evaluation and research (CDER) Center for Biologics evaluation and research (CBER) European Union: European Medicines Evaluation Agency (EMEA) & European Directorate for the Quality of Medicines (EDQM)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 30
  3. 3. US and EUROPE - FILINGUSA Center for Drug evaluation and research (CDER) New Drug Application (NDA) Abbreviated New Drug Application (ANDA)EUROPE Nationalize Process (NP) Decentralized Process (DCP) Mutual Recognition Process (MRP) Centralized Process (CP) Marketing Authorization Application (MAA)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 30
  4. 4. Overview of the USFDAGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 4 of 30
  5. 5. Regulatory Submission in USA Dossier is submitted in eCTD format Submission to Center for Drug Evaluation and Research (CDER) ( ) ANDA Certification clauses Paragraph I – Required Patent information has not been filed. Paragraph P h II – P Patent h expired. has i d Paragraph III – Patent not expired, will be expired on specific date. Paragraph IV – Patent is invalid or non infringed by generic applicantGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 5 of 30
  6. 6. NDA / ANDAGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 6 of 30
  7. 7. NDA / ANDA ContentGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 7 of 30
  8. 8. NDA / ANDA Content (cont.)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 30
  9. 9. Regulatory Submission in Europe EU submission process b i i National Process (NP) Decentralized P D t li d Process (DCP) Mutual Recognition Process (MRP) Centralized Process (CP)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 9 of 30
  10. 10. National Process (NP) Individual applications to each country within the EU EU. Used for products that fall outside the scope of the EMA centralized procedure. If application rejected in one country, can still access other EU countries. Separate applications required for each country. Unique requirements and formats may be required.Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 10 of 30
  11. 11. Decentralized Process (DCP) Simultaneous authorization in numerous countries in the EU. More efficient than national authorization Positive outcome results in numerous country approvals. approvals Applicant can select which countries to apply to; to does not ha e to be all EU countries. have co nt ies A negative decision on an application may affect numerous countries. countriesGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 11 of 30
  12. 12. Mutual Recognition process (MRP) Review by one country and other countries accept the decision. p Only one application needs to be submitted. A negative outcome can affect numerous countries. Individual national approvals can add significant time to the process.Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 12 of 30
  13. 13. Centralized Process (CP) One application applies to all countries in the EU EU. Relatively quick procedure. A positive outcome is very beneficial to the Applicant. CP is applicable for biologic products or other products using high-technology procedures; products for HIV/AIDS, cancer, diabetes, neurodegenerative disease, auto-immune or other dysfunctions, and viral diseases; y , ; products for orphan conditions; and other new active substances at the request of the applicant. A negative outcome will affect access to the entire EU EU.Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 13 of 30
  14. 14. Comparison of drug p p g product dossier submission process in US & EUGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 30
  15. 15. In EU : EMEA have administrative framework where National agencies act as scientific g reviewers In FDA : Scientific reviewers are within Agency fGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 30
  16. 16. Registration process USGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 30
  17. 17. Registration process EUGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 30
  18. 18. Post approval changes US Vs EUGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 30
  19. 19. Post approval changes (US)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 30
  20. 20. Post approval changes (EU)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 30
  21. 21. Administrative Requirement US EU Application ANDA MAA Approval time line ~18 Month ~12 Month Debarment Required Not Required Certification Pharmacovigilance Not Required Required Agent Authorization Required Not RequiredGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 21 of 30
  22. 22. Manufacturing And Control Requirement US EU No.of batches 1 3 Process Validation PV commitment PV scheme required i d Required R i d Executed BMR Required Not required Comparability Protocol Required Not required Certificates of Not required Mandatory Suitability TSE/BSE-free - Mandatory statementGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 22 of 30
  23. 23. Finished Product Control Requirement US EU Assay 90 -100 % 95 -105 % Identification Test Single Test Additional test required Colour Identification Not Required Required Water Content Required Not Required Disintegration Test Not Required RequiredGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 23 of 30
  24. 24. Labeling Requirement Requirement US EU NDC No. Required (10 digit) Not Required (National Drug Code ) Prescription Status Rx POM (Prescription-only medicines) Labels Vials/Carton/PIL Vials/Cartons/PIL/SmPC Side Sid by b side Vi l /C t /PIL id Vials/Carton/PIL Not Required N tR i d comparisonGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 24 of 30
  25. 25. Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 25 of 30
  26. 26. Stability Requirement Requirement US EU No.of batches 1 2 Date and time of 3 Month accelerated 6 Month accelerated submission and 3 month log term and 6 month log term Container Inverted and upright Do not addressed orientationGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 26 of 30
  27. 27. Bioequivalence Requirement OGD: Office of Generic DrugsGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 27 of 30
  28. 28. US & EU Facility AuditGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 28 of 30
  29. 29. Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 29 of 30
  30. 30. Thank Th k youGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 30 of 30

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