Introduction to Pharma regulatory affairs

1. Pharma
Regulatory Affairs
Girish Swami, (M.Pharm, PGDIPR, PGDDRA)
International Regulatory Affairs Dept.
g y p
+91-9881492626
pr.girish@gmail.com

2. Regulatory Affairs
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 27

3. Role of RA
To keep track of the ever-
changing legislation
Registration documents to
regulatory agencies
To i
T give strategic and t h i l
t t i d technical
advice to R&D, Production, QC
dept etc.
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 27

4. You should know
What
Wh t is
i Dossier ?
D i
What is DMF ?
What is CTD / eCTD ?
What is NDA / ANDA and MAA ?
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5. What is Dossier ?
Dossier i a collection or fil of d
D i is ll i file f documents that
h
contains all the technical data of pharmaceutical
p
product to be approved / registered / marketed in
pp g
a country.
It most commonly called as Registration Dossier,
In US : New Drug Application (NDA),
In EU : Marketing Authorization Application (MAA)
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6. What is DMF ?
Drug Master File (DMF)
US United State Drug Master File (US-DMF)
EU European Drug Master File (EDMF) or
Active Substance Master File (ASMF)
[Applicant’s Part / Open Part and Restricted part / Closed part]
DMF Types
Type I – Mfg. Site, Facilities, Operating Procedures, and Personnel
(no longer applicable)
Type II - DS, Intermediate & Material Used in Their Preparation or Drug Product
Type III - Packaging Material
Type IV - Excipient, Colorant, Flavor or Material Used in Their Preparation
Type V - FDA Accepted Reference Information (FDA discourages its use)
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7. What is CTD/eCTD ?
Common Technical Document (CTD): Its an
format set by ICH which was agreed by the
Regulatory Agencies of Europe, Japan & the US.
Its electronic version called as
electronic Common Technical Document
(eCTD).
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8. The CTD Triangle
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9. CTD Modules
Module 1 – Administrative Information
(Region Specific)
Module 2 – CTD Summaries (QOS)
Module 3 – Quality (CMC)
Module 4 – Non-Clinical Study Reports
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Module 5 – Clinical Study Reports
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 9 of 27

10. Module 1
Administrative Information (Region Specific)
Should contain documents specific to each region
For USA For EU
Application form 356h Application form
Proposed l b l
d label Summary of product characteristics
Patent certification / Labelling text and mock-ups
information Information about the experts
Debarment certificate
Environmental risk assessment
Letter of Authorization
(LoA)/ DMF letter Description of the
pharmacovigilance system
Labeling text
Risk management plan
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11. Module 2
odu e
CTD Summaries (QOS)
It contain 7 sections in the following order:
2.1 CTD TOC (Module 2-5)
2.2
2 2 CTD Introduction
2.3 Quality Overall Summary
2.4 Non-clinical
2 4 Non clinical Overview
2.5 Clinical Overview
2.6 Non-Clinical
2 6 Non Clinical Summary
2.7 Clinical Summary
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12. Module 3
Quality (CMC)
3.1
3 1 TOC of M d l 3
f Module
3.2 Body of Data
3.2.S - Drug substance
3.2.P - Drug product
3.2.A - Appendices
d
3.2.R - Regional Information
3.3
3 3 Literature references
f
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 12 of 27

13. Module 4
Non-Clinical Study Reports
4.1
4 1 TOC of M d l 4
f Module
4.2 Study reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
l
4.3 Literature References
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14. Module 5
Clinical Study Reports
5.1
5 1 TOC of Module 5
5.2 Tabular listing of Clinical Studies
5.3 Clinical study reports
5.3.1 Reports of Biopharmaceutical (BA-BE) Study
5.3.2 Reports of Pharmacokinetic (biomaterial) study
5.3.3 Reports of Pharmacokinetic (PK) Studies
5.3.4 Reports of Pharmacodynamic (PD) Studies
5.3.5 Reports of Efficacy and Safety studies
5.3.6 Reports of Post-Marketing experience
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5.3.7 Case Report Forms & Individual patient listings
5.4 Literature References
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15. eCTD
Its electronic version of CTD so called as
CTD,
electronic Common Technical Document
(eCTD).
eCTD composed of two types of specification
Content specification – As defined by ICH
p y
Technical specification – Electronic software's
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16. eCTD is highly recommended by USFDA for
NDAs, BLAs, DMFs and INDs filing
From year 2010 European Union also make
y p
compulsory for electronic CTD submission to all
procedures
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17. eCTD Characteristics
Structure
All Modules 1 to 5 have granularity
options.
PDF documents linked via XML
backbone
Increased document granularity
granularity.
Transparency of entire submission
Ease of navigation and review
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18. eCTD Template
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19. M1
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 27

20. M2
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21. M3
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 21 of 27

22. M4
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23. M5
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 23 of 27

24. Benefits of eCTD
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 24 of 27

25. Cou
Country wise Regulatory age cy
y se egu a o y agency
websites
India
www.cdsco.nic.in
http://www.cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
USA
http://www.fda.gov/drugs/default.htm
h // fd /d /d f l h
Orange book:http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
European
Home page: www.emea.europa.eu
Guidelines page: http://www.emea.europa.eu/htms/human/humanguidelines/quality.htm
UK
Home page: www.mhra.gov.uk
Guidelines page: http://www.mhra.gov.uk/Publications/Regulatoryguidance/index.htm
Australia
Home page: www.tga.gov.au
Guidelines page: http://www tga gov au/pmeds/pmeds htm
http://www.tga.gov.au/pmeds/pmeds.htm
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 25 of 27

26. Cou
Country wise Regulatory age cy
y se egu a o y agency
websites (cont.)
International conference on harmonization (ICH)
( )
Home page: www.ich.org
Guidelines page: http://www.ich.org/cache/compo/276-254-1.html
Canada
Home page: www.hc-sc.gc.ca
H h
Guidelines page: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/index-eng.php
South Africa
Home page: http://www.mccza.com
Guidelines : http://www.mccza.com/showdocument.asp?Cat=17&Desc=Guidelines%20-
%20Human%20Medicines
Singapore
Home page: www.hsa.gov.sg
H h
Guidelines : http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/regulatory_guidances.html
Brazil
Home page: http://www.anvisa.gov.br/eng/index.htm
p g p // g / g/
Guidelines page: http://www.anvisa.gov.br/eng/legis/index.htm#3
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 26 of 27

27. Thank
Th k you
Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 27 of 27