US and EU Submission – Comparative
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The document compares the regulatory processes for drug product submissions in the US and EU. In the US, applications are submitted to the FDA's Center for Drug Evaluation and Research and can be New Drug Applications or Abbreviated New Drug Applications. In the EU, applications are submitted through national regulatory authorities or through the centralized European Medicines Agency process. The key differences between the US and EU processes include differences in application types, approval timelines, post-approval change requirements, manufacturing standards, quality testing standards, and facility inspection processes.
US and EU Submission – Comparative
- 1. US and EU Submission : Comparative Girish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
- 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. US and EUROPE - FILING USA 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. Overview of the USFDA Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 4 of 30
- 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 applicant Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 5 of 30
- 6. NDA / ANDA Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 6 of 30
- 7. NDA / ANDA Content Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 7 of 30
- 8. NDA / ANDA Content (cont.) Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 30
- 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. 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. 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. countries Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 11 of 30
- 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. 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. Comparison of drug p p g product dossier submission process in US & EU Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 30
- 15. In EU : EMEA have administrative framework where National agencies act as scientific g reviewers In FDA : Scientific reviewers are within Agency f Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 30
- 16. Registration process US Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 30
- 17. Registration process EU Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 30
- 18. Post approval changes US Vs EU Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 30
- 19. Post approval changes (US) Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 30
- 20. Post approval changes (EU) Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 30
- 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 Required Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 21 of 30
- 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 statement Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 22 of 30
- 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 Required Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 23 of 30
- 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 comparison Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 24 of 30
- 25. Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 25 of 30
- 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 orientation Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 26 of 30
- 27. Bioequivalence Requirement OGD: Office of Generic Drugs Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 27 of 30
- 28. US & EU Facility Audit Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 28 of 30
- 29. Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 29 of 30
- 30. Thank Th k you Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 30 of 30