Transcript
Page 1: Regulatory Affairs Profession

Regulatory Affairs

Profession

Ms. Anagha Maharao

Institute of Pharmaceutical ManagementEscalating Efficiency of Pharma Aspirants

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• 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

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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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