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.
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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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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