Regulatory Affairs Profession

The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.

1. Regulatory Affairs
Profession
Ms. Anagha Maharao
Institute of Pharmaceutical Management
Escalating Efficiency of Pharma Aspirants

2. •
Pharmaceutical & Clinical Research Industry most
regulated among all the industries.
•
Every drug before getting market approval must
undergo rigorous scrutiny and clinical
trials to ensure its Safety, Efficacy &
Quality.
•
Standards are set by regulatory
authorities.
•
RA department acts as a crucial link between
company, products & regulatory authorities.
Introduction
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Institute ofPharmaceutical Management

3. What is DRA??
•
Unique mix of science and management to achieve a
commercially important goal.
•
It touches everything relating to drugs from the
development manufacture and marketi ng.
•
RA takes care of
I
Design = Development Plan
I
Co-ordination = Writing/
reviewing, supervising
I
Construction = Assembling &
Submission management
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Institute ofPharmaceutical Management

4. •
Lifecycle management ranges from
Drug Discovery post-marketing stage o f the
process.
•
From Drug development to commercialization, each
step is regulated.
Scope
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Institute ofPharmaceutical Management

5. Responsibilities of RA
professional
•
Keep up-to-date about international
legislation, guidelines and customer practices.
•
Update with company's product range.
•
Compliance of company's product with
current regulations
•
Impart training to R&D, Pilot plant, ADL on
current regulatory requirements
•
Formulate regulatory submission strategies.
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Institute ofPharmaceutical Management

6. •
Prepare IMPD, DMF, ANDA, MAA, Dossiers
amendments & supplements etc as per
regional guidelines, submit them to
regulatory authorities in a specified time
frame
•
Monitor progress of all registration
submissions
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Responsibilities of RA
professional [Contd…]
Institute ofPharmaceutical Management

7. •
Respond to queries as they arise and ensure
that registration/approvals are granted
without delay.
•
Handle regulatory and customer inspections,
review audit reports and compliance
•
Arranges consultations and meetings
between the firm and government
regulatory agencies
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Responsibilities of RA
professional [Contd…]
Institute ofPharmaceutical Management

8. 9
•
Company success
depends on reduction of
time taken for a drug to
reach market.
•
Inadequate reporting of
data may prevent a
timely positive
evaluation of a
marketing application
•
Proper conduct of RA
activities is therefore
of considerable
economic importance
for the company.
NO DMF/
DOSSIER NO REGISTRATION
NOSALE
Importance of RA
Institute ofPharmaceutical Management

9. Regulatory Agencies

10. Country Name of Regulatory Authority Website USA Food and Drug Administration
[FDA]
www.fda.gov
Europe European Directorate for the
Quality of Medicines and
Healthcare (EDQM)
www.edqm.eu
European Medicines Agency (EMA)
www.ema.europa.eu
Heads of Agencies for the European
Union
http://www.hma.eu/
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Institute ofPharmaceutical Management

11. Country Name of Regulatory Authority Website Japan Ministry of Health, Labourand
Welfare (MHLW)
www.mhlw.go.jp/english
Pharmaceuticals and Medical Devices
Agency (PMDA)www.pmda.go.jp/english/
UK Medicines and Healthcare products
Regulatory Agency (MHRA)
www.mhra.gov.uk
India Central Drugs Standard Control
Organization.
www.cdsco.nic.in
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Institute ofPharmaceutical Management

12. How
to Keep Up With the Constantly
Changing Regulatory Landscape? R
Monitor Agency’s
websites
R
Subscribe to relevant
journals, newsletters
R
Get daily e-mails
from regulatory
websites, commercial
information provider
websites
22
RAttend relevant
conferences/advis
ory meetings
RTalk to colleagues
and consultants
REmploy a
regulatory
information
databaseIn-house
or Paid
RJoining
information blogs
Institute ofPharmaceutical Management