Regulatory affairs is a profession that developed to oversee the regulation of products like pharmaceuticals, medical devices, and cosmetics by government agencies to ensure public health and safety. Regulatory affairs departments act as the interface between companies in regulated industries and regulatory agencies around the world. They track changing legislation, submit registration documents to agencies, and provide strategic and technical advice to other departments like R&D, manufacturing, and quality assurance.

1. Global Institute of
Biosciences and Technology

2. What is regulatory affairs?
Regulatory affairs is a comparatively new profession which developed from the
desire of governments to protect public health by controlling the safety and
efficacy of products in areas including pharmaceuticals, veterinary medicines,
medical devices, pesticides, agrochemicals, cosmetics and complementary
medicines.
Regulatory Affairs in the pharma industry may be defined as "The interface
between the pharmaceutical company and the regulatory agencies across the
world.“
Regulatory Agencies
Regulatory Affairs Department
Department A Department B Department C Department D
Pharmaceutical Company
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3. Role of RA
 To keep track of the ever
changing legislation
 Registration documents to
regulatory agencies
 To give strategic and technical
advice to R&D, Production, QC
Department etc.
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4. What does a DRA department required in a
Pharmaceutical organization?
 Pharmaceutical industry is the most regulated of all the
industries.
 Regulations are put in order to develop the most efficient
and safe pharmaceutical products.
 It takes more than 8 to 15years to develop a new drug
product & costs more than $800 million.
 Regulatory affairs provides insight / guidance into this
development through agency wisdom collected in
guidance, previous experience, market precedence, etc.
and hence helps to reduce the number of development
failures.
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5. Which departments are assisted by DRA
Department?
Drug Regulatory Authorities
(across the world)
 CDSCO- India
 USFDA- United States
 EMEA- European
countries
 MHRA- United Kingdom
 TGA- Australia
 MCC- South Africa
Internal Departments of
Organizations
 Product Developments
 Clinical Research &
Trials
 Licensing
 Manufacturing
 Quality Assurance &
Control
 Marketing
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6. On what issues does DRA department provide
assistance?
 Licensing
 Registration
 Development
 Manufacturing
 Quality Guidance
 Pricing
 Marketing
 Pharmacovigilance
 GMP
 GLP
 GCP
 Patent
 Copyright
 Trademark
………..& many more
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7. You should know
 What is Dossier?
 What is DMF?
 What is CTD / eCTD?
 What is NDA / ANDA or MAA?
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8. What is Dossier?
Dossier is a collection or file of documents that contain all
the technical data of pharmaceutical product to be
approved / registered / marketed in a country.
It is most commonly called as Registration Dossier,
In US: New Drug Application (NDA)
In EU: Marketing Authorization Appliation (MAA)
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9. What is DMF?
Drug Master File (DMF)
Type I- Mfg. sites, Facilities, Operating Procedures and Personnel (no
longer applicable)
Type II- DS, Intermediate and 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)
US United State Drug Master File (US- DMF)
EU European Drug Master File (EDMF) or
Active Substance Master File (ASMF)
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10. What is CTD / eCTD?
Common Technical Document (CTD), It is an format
set by ICH which was agreed by Regulatory Agencies
of Europe, Japan and the US.
Its electronic version called as electronic Common
Technical Document (eCTD)
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11. GIBT INDIA

12. For USA
Application formm 356h
Proposed label
Patent Certification /Information
Debarment Certificate
Letter of Authorization
(LOA)/DMF Letter
Labeling Text
For EU
Application form
Summary of product
characteristics
Labelling text andmock-ups
Information about the experts
Environmental riskassesment
Description of the
pharmacovigilance system
Risk management plan
Module 1
Administrative Information(Region Specific)
Should contain documents specific to each region
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13. Module 2
CTD Summaries (QOS)
 It contains 7 Sections in the following order:
 CTD DOC (Module 2- 5)
 CD Introduction
 Quality Overall Summary
 Non- Clinical Overview
 Clinical Overview
 Non Clinical Summary
 Clinical Summary
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14. Module 3
Quality (CMC)
 TOC of Module 3
 Body of Data
a) Drug Substance
b) Drug Product
c) Appendices
d) Regional Information
 Literature References
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15. Module 4
Non- Clinical Study Report:
 TOC of Module 4
 Study Reports
a) Pharmacology
b) Pharmacokinetics
c) Toxicology
 Literature References
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16. Module 5
Clinical Study Reports
 TOC of Module 5
 Tabular listing of Clinical Studies
 Clinical study reports
a) Reports of Biopharmaceutical (BA-BE) Study
b) Reports of Pharmacokinetic (biomaterial) study
c) Reports of Pharmacokinetic (PK) Studies
d) Reports of Pharmacodynamic (PD) Studies
e) Reports of Efficacy and Safety studies
f) Reports of Post – Marketing experience
g) Case Report Forms & Individual patient listings
 Literature References
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17. eCTD
Its electronic version of CTD, so called as electronic Common Technical
Document (eCTD).
 eCTD composed of two types of specification
a) Content Specification- As defined by ICH
b) Technical Specification- Electronic software’s
CTD TOC (PDF) (Paper)
eCTD XML
Backbone
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18.  eCTD is highly recommended by USFDA for NDAs, BLAs,
DMFs and INDs filing
 From year 2019 European Union also make compulsory
for electronic CTD submission to all procedures
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19. eCTD Characteristics
Structure
 All modules 1 to 5have granularity options
 PDF documents linked via XML backbone
 Increased document granularity
 Transparency of entire submission
 Ease of navigation and review
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20. Benefits of eCTD
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