Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research, ensuring the safety, efficacy, and quality of drugs and medical products. Their responsibilities encompass a wide range of activities at various stages of clinical research and drug development: Study Oversight: Regulatory agencies review and approve clinical trial protocols, including the study design, patient eligibility criteria, and endpoints. They assess whether trials are ethically conducted, adhering to Good Clinical Practice (GCP) standards. Patient Safety: Ensuring the safety of study participants is a paramount role. Regulatory agencies review adverse event reporting systems, monitoring practices, and protocols for participant safety. They require prompt reporting of serious adverse events and safety updates throughout the trial. Regulatory Approvals: Regulatory agencies grant approval for the initiation of clinical trials through the Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) processes. Subsequently, they evaluate New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) to determine whether a drug is safe and effective for market authorization. Data Review: Regulatory agencies meticulously review clinical trial data to assess the efficacy and safety of investigational drugs. This includes an evaluation of patient outcomes, statistical analyses, and the interpretation of results. Risk-Benefit Assessment: They weigh the benefits of a new drug or medical product against its potential risks. This assessment guides decisions regarding market authorization and the inclusion of warnings, precautions, and contraindications in product labeling. Post-Marketing Surveillance: After a drug is approved, regulatory agencies continue to monitor its safety and efficacy in real-world settings through post-marketing surveillance programs. This includes assessing adverse event reports, epidemiological studies, and real-world evidence. Labeling and Packaging: Regulatory agencies have a role in approving the labeling, packaging, and instructions for use of drugs. They ensure that information is clear, accurate, and up-to-date. Pharmacovigilance: They establish and oversee pharmacovigilance systems for ongoing monitoring of drug safety. This involves collecting, analyzing, and disseminating information on adverse drug reactions. Quality Control: Regulatory agencies ensure that manufacturing facilities and processes for drug products adhere to Current Good Manufacturing Practice (cGMP) standards to guarantee product quality and consistency. Emergency Use Authorization: During public health emergencies, regulatory agencies can grant Emergency Use Authorizations (EUAs) to allow the use of investigational drugs or medical products outside of traditional regulatory pathways.

1. Welcome
Role of Drug Regulatory Agencies
Mavya Padamati
B Pharmacy
193/092023
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2. CONTENTS
A. Introduction
B. Why Do We Need Drug Regulatory Agencies?
C. Functions of Drug Regulatory Agencies
D. Regulatory Agencies
E. US-FDA
F. CDSCO
G. Drug Approval process
H. Conclusion
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3. INTRODUCTION Definition
Drug : Any synthetic, semisynthetic, or natural
chemical substance used in the treatment, prevention,
or diagnosis of disease, or for other medical reasons.
Drug Regulations: The combination of legal,
administrative, and technical measures that
governments take to ensure the safety, efficacy, and
quality of medicines, as well as the relevance and
accuracy of product information
Regulatory agency: It is also known as a regulatory
authority or regulatory body, is a government
organization or authority responsible for overseeing
and regulating specific industries, sectors, or activities
to ensure compliance with laws, regulations, standards,
and best practices.
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4. Why DoWe Need Drug Regulatory
Agencies?
▪ Drug regulatory agencies are
responsible for ensuring public
safety by ensuring the safety and
effectiveness of drugs and medical
products.
▪ They establish and enforce standards
for manufacturing, packaging, and
labeling, evaluate drug efficacy,
manage risks, oversee the approval
process, and monitor post-market
surveillance.
▪ They promote consistency and
standards, often collaborating with
international counterparts to
harmonize standards worldwide.
▪ They also oversee marketing and
promotion to prevent false claims
and ensure accurate information.
▪ They play a crucial role in
maintaining public health and
promoting ethical practices in the
pharmaceutical industry.
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5. Functions of Drug Regulatory Agencies
• Product registration (drug evaluation
and authorization), and monitoring of
drug efficacy and safety.
• Regulation of drug manufacturing,
importation, and distribution.
• Regulation & Control of drug
promotion and information.
• Adverse drug reaction (ADR)
monitoring.
• Licensing of premises, persons and
practices.
• Main goal of drug regulation is to
guarantee the safety, efficacy and
quality of drugs
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6. Regulatory Agencies
1. Food and Drug Administration (FDA) - United States
2. European Medicines Agency (EMA) - European
Union
3. Health Canada - Canada
4. Pharmaceuticals and Medical Devices Agency
(PMDA) - Japan
5. Therapeutic Goods Administration (TGA) - Australia
6. Medicines and Healthcare products Regulatory
Agency (MHRA) - United Kingdom
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7. 7. Central Drugs Standard Control Organization
(CDSCO) - India
8. National Medical Products Administration (NMPA) -
China
9. Pharmacy and Poisons Board (PPB) - Kenya
10. Health Sciences Authority (HSA) - Singapore
11. Health Products Regulatory Authority (HPRA) -
Ireland
12. Brazilian Health Regulatory Agency (ANVISA) -
Brazil
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Regulatory Agencies

8. US-FDA UNITED STATES- FOOD AND DRUG ADMINISTRATION
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▪ The Food and Drug Administration (FDA or
USFDA) is an agency of the United States
Department of Health and Human Services
▪ It is responsible for regulating and supervising the
safety of foods, dietary supplements, drugs, vaccines,
biological medical products, blood products, medical
devices, radiation-emitting devices, veterinary
products, and cosmetics.
▪ The Food and Drug Administration (FDA) is
responsible for protecting the public health by
providing accurate, science-based health information
to the public.

9. Functions
9
• Drug Approval and Evaluation:The FDA evaluates and approves new drugs and
biologics before they can be marketed in the United States.
• It assesses data from preclinical and clinical trials to determine the safety and
efficacy of drugs.
• Generic Drug Approval:The FDA reviews and approves generic versions of
brand-name drugs once their patents have expired.
• Over-the-Counter (OTC) Drugs:The FDA regulates OTC drugs to ensure their
safety and effectiveness for consumer use.
• Drug Labeling and Packaging:The FDA reviews and approves drug labeling
and packaging to ensure they provide accurate information to healthcare
professionals and consumers.
• Post-Market Surveillance:The FDA continuously monitors the safety of drugs
once they are on the market.

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• Regulation of Compounded Drugs:The FDA oversees the regulation of compounded
drugs to ensure they meet safety and quality standards.
• Orphan Drug Designation:The FDA grants orphan drug designation to drugs developed
for rare diseases, providing incentives for their development and marketing.
• Regulation of Investigational New Drugs (INDs):The FDA oversees the investigational
use of new drugs in clinical trials through the IND application process.
• Controlled Substances:The FDA plays a role in regulating controlled substances,
including prescription pain medications and other drugs with a potential for abuse.
Functions

11. CDSCO CENTRAL DRUG STANDARD CONTROL ORGANIZATION
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▪ It is the National Drug Regulatory
Authority of the Government of India.
▪ Central Drugs Standard Control
Organization (CDSCO) is regulatory
control over the quality of drugs, cosmetics
and notified medical devices in the country.
▪ It is the Central Drug Authority for
discharging functions assigned to the
central Government under the Drugs
and Cosmetics Act.

12. Functions
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▪ Approval of new drugs and clinical trials
▪ Import Registration and Licensing
▪ License approving of Blood Banks, LVPs(large volume
parenterals), Vaccines, r-DNA products & some Medical
Devices.
▪ Amendment to D &C Act and Rules
▪ Banning of drugs and cosmetics
▪ Grant of Test License, Personal License, NOCs for
Export
▪ Testing of New Drugs
▪ Oversight and market Survillance through Inspectorate
of Centre Over and above the State Authority

13. Drug Approval Process
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Pre-Clinical
Testing
Clinical Trials
New Drug
Application
(NDA)
Technical
Committee
Review
Drug Control
Authority
Approval
Manufacturing
Inspection
GMP
Approval and
Market Entry
Post-Market
Surveillance

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CONCLUSION
In conclusion, drug regulatory agencies play a pivotal role in safeguarding public
health and ensuring the safety, efficacy, and quality of pharmaceutical products.
Their multifaceted responsibilities encompass evaluating new drugs, overseeing
clinical trial etc, and providing guidance to the industry and healthcare
professionals.
The functions of regulatory agencies are essential in maintaining trust in the
pharmaceutical industry, fostering innovation, and promoting public health. As
medical science advances and new challenges arise, these agencies continue to
adapt and evolve, remaining dedicated to their mission of upholding the highest
standards in drug regulation and ensuring the well-being of individuals and
communities worldwide.

15. ThankYou!
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