Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research: Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated. Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting. Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval. Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients. Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise. Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research. International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.

1. Bogireddy Indra Sena Reddy
B. Pharmacy
023/022024
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ROLE OF DRUG REGULATORY AGENCIES

2. Index
• What is a Drug Regulatory Agency?
• Why do we need the Drug Regulatory Agency? The Goal
of the Drug Regulatory Agency
• Roles of the Drug Regulatory Agency
• Major Drug Regulatory Agencies Worldwide
• Drug Regulatory Systems in India
• CDSCO INTRODUCTION
• CDSCO functions
• CDSCO offices and their respective roles organization
chart
• Conclusion
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3. What is Drug Regulatory Agency?
Regulatory authorities and organizations are the government bodies
responsible in effective drug regulation required to ensure the safety,
efficacy, and quality of drugs, medical devices, and other healthcare
products, as well as the accuracy and appropriateness of the drug
information available to the public.
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4. Why Do We Need Drug Regulatory Agency?
People and Governments willing to spend money on drugs for
many reasons so, it must be safe, effective and good quality and
used appropriately.
This means, in turn, that development, production, importation,
exportation and subsequent distribution of drugs must be regulated
to ensure that they meet prescribed standards.
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5. • Prepare and Maintain Regulations: Regulatory bodies establish and update regulations
that govern the development, manufacturing, testing, and marketing of pharmaceuticals
and medical devices.
• Drug Discovery: Regulatory bodies provide guidance and facilitate pre-clinical testing to
assess a drug’s potential efficacy and safety before human testing.
• Conducting, Control, and Regulating Phase Studies in Clinical Research: Regulatory
bodies oversee clinical trials, ensuring ethical conduct and scientific rigor. They review
and approve study protocols, informed consent forms, and other essential documents
before trials begin.
• Drug Approval: Regulatory bodies evaluate data submitted by pharmaceutical companies
and decide whether to approve a drug for marketing and use. Approval is granted only if
benefits outweigh risks and quality standards are met.
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Role of Drug Regulatory Agency

6. • Drug Evaluation: Regulatory bodies critically review pre-clinical and clinical trial data
to assess safety, efficacy, and quality data submitted by pharmaceutical companies.
• Product Labelling and Packaging: Regulatory bodies mandate accurate and
informative labeling and packaging, providing essential information about the drug.
• Set standards for drug quality: Drug regulatory authorities set standards for drug
quality to ensure that drugs meet certain quality requirements.
• Cooperate with other regulatory authorities: Drug regulatory authorities cooperate
with other regulatory authorities around the world to share information and
collaborate on research.
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7. • Post-Marketing Surveillance: Regulatory bodies monitor a drug’s safety and
effectiveness post-approval by collecting and analysizing data on adverse reactions
and other safety concerns reported.
• Inspections and Audits: Regulatory bodies conduct inspections and audits of
manufacturing facilities, clinical trial sites, and distribution centres to ensure
compliance with quality standards and regulations.
• Pharmacovigilance: Regulatory bodies manage pharmacovigilance systems to track
and evaluate adverse drug reactions and other safety-related data, addressing
potential safety issues associated with drugs.
• Public Education: Regulatory bodies play a role in educating the public about safe
medicine and device use. They provide information about potential risks and side
effects and promote awareness about reporting adverse reactions.
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8. 8
Role Regulatory Agencies Worldwide

9. Functions of CDSCO
- Approval of new drugs and clinical trials
- Import Registration and Licensing
- License approving of Blood Banks, LVPs, Vaccines, r-DNA products & some Medical
Devices (CLAA Scheme)
- 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
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10. CDSCO offices and their respective roles
• (Text here)
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11. Drug regulatory bodies are the silent sentinels of public health,
safeguarding our well-being by scrutinizing, certifying, and controlling
the medicines through out it's life cycle that touch our lives, ensuring
that each pill we take, each injection we receive, is a promise of health
and healing.
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Conclusion

12. Thank You!
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