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.

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)
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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)
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4. Overview of the USFDA
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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
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6. NDA / ANDA
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7. NDA / ANDA Content
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8. NDA / ANDA Content (cont.)
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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)
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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.
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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
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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.
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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.
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14. Comparison of drug p
p g product
dossier submission process
in US & EU
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15. In EU : EMEA have administrative framework
where National agencies act as scientific
g
reviewers
In FDA : Scientific reviewers are within Agency
f
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16. Registration process
US
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17. Registration process
EU
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18. Post approval changes
US Vs EU
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19. Post approval changes (US)
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20. Post approval changes (EU)
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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
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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
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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
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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
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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
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27. Bioequivalence Requirement
OGD: Office of Generic Drugs
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28. US & EU
Facility Audit
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29. Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 29 of 30

30. Thank
Th k you
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