Call Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
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
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
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
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