This document discusses approved regulatory bodies and agencies that regulate drugs. It provides information on regulatory authorities in countries like the US, EU, India, Japan, and their functions. The key regulatory bodies mentioned are the US FDA, EU, India's CDSCO under the Ministry of Health and Family Welfare. The functions of regulatory bodies include drug evaluation, monitoring safety and efficacy, licensing, and adverse reaction monitoring. They aim to ensure drug safety, efficacy, and quality. Harmonization of regulatory standards globally and strengthening authorities are needed to regulate the pharmaceutical industry effectively.

1. Approved Regulatory Bodies
And Agencies
SMT R.D Gardi B.Pharmacy College Nyara, Rajkot
Guided by - Ms. Kajal Pradhan
Assistant professor
. M.Pharm (pharmaceutics)
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Presented by- Akshita Dholakiya
B.Pharm

2. Introduction
• Regulatory authority and organizations are responsible in
effective drug regulation required to ensure the safety, efficacy
and quality of drugs, as well as the accuracy and
appropriateness of the drug information available to the
public.
• Regulatory bodies provide strategic, tactical and operational
direction and support for working within regulations to
expedite the development and
delivery of safe and effective healthcare products to individuals
around the world.
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3. Country and its Regulatory Authority 2
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4. Functions
• Product registration drug evaluation and authorization, and monitoring of drug
efficacy and safety.
• Regulation of drug manufacturing importance and distribution.
• Regulation and control of drug promotion and information.
• Adverse drug reaction (ADR) monitoring.
• Licensing of premises, person and practices.
• Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs.
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5. Clinical investigation
US: IND- Investigational new drug( Application)
EU: CTA/CTX- Clinical Trial Authorization Application
Marketing Approval
US: NDA- New Drug Application
• ANDA- Abbreviated New Drug
• BLA- Biological License Application
EU: MAA- Marketing Authorization Application
• CTD- Common Technical Document common format for . .
. marketing authorization (registration)
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6. Labeling
• US: Primary and Secondary Package Insert (PI),
Patient Packaging Insert (PPI),
Structure Product Labeling (SPL)
• EU: Summary of Product Characteristics (SPC),
European PublicAssessment Report (EPAR)
.
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7. Challenges
 The major challenges of these regulatory bodies
are
1 To promote public health and protect the public
from harmful and dubious drugs.
2 To establish proper legalization covering all
products with a medicinal claim and all relevant
pharmaceutical activities, whether carried out by
the public or the private sector.
3 To increase worldwide regulatory growth to
ensure safety of people
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8. Why we need it ?
1.More centralized procedures in drug regulation
2.Harmonization of regulatory norms
3. Strengthening the regulatory authorities
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9. Medical Regulatory Structure in India
MINISTRY OF HEALTH
AND FAMILY WELFARE
NATIONAL DRUG
AUTHORITY
CDSCO NEW DELHI
STATE LEVEL
AUTHORITY
State F and D
administration for
each state and
territories
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10. CDSCO
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11. CDSCO FDA Bhawan New Delhi
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13. Japan
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14. Europe
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15. Reference
1. Rohilla, Dhulichand; Dureja, Harish, New Drug Approval Process:
Regulatory View, Pharmainfo.net, 2010.(assessed on Sept 5th 2011).
2. Government and regulatory bodies around the world,
pharmweb.net/pwmirror/pwk/pharmwebk.html.(assessed on Sept
8th 2010).
3. https://www.pharmatutor.org/articles/pharmaceutical-regulatory-
agencies-and-organizations-around-world-scope-challenges-in-drug-
development.
4. Pharmaceutical Regulatory Affairs: An Introduction for Life Scientists
by CF Harrison.
5. A Textbook of Pharmaceutical Regulatory Science by Kommu Pradeep.
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