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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.
Regulatory Affairs
Profession
Ms. Anagha Maharao
Institute of Pharmaceutical ManagementEscalating Efficiency of Pharma Aspirants
• 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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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 marketing.
• RA takes care of
� Design = Development Plan
� Co-ordination = Writing/
reviewing, supervising
� Construction = Assembling &
Submission management
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• Lifecycle management ranges from
Drug Discovery post-marketing stage of the
process.
• From Drug development to commercialization, each
step is regulated.
Scope
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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.6
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• 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
submissions7
Responsibilities of RA
professional [Contd…]
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• 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 agencies8
Responsibilities of RA
professional [Contd…]
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• 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
NO SALE
Importance of RA
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Regulatory Agencies
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/ 10
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Country Name of Regulatory Authority Website
Japan Ministry of Health, Labour and
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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How to Keep Up With the Constantly
Changing Regulatory Landscape?
� Monitor Agency’s
websites
� Subscribe to relevant
journals, newsletters
� Get daily e-mails
from regulatory
websites, commercial
information provider
websites
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� Attend relevant conferences/advisory meetings
� Talk to colleagues and consultants
� Employ a regulatory information database In-house or Paid
� Joining information blogs
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