Various countries around the world have distinct drug regulatory bodies tasked with overseeing the safety, efficacy, and quality of pharmaceutical products within their borders. These regulatory agencies play a crucial role in ensuring that medications meet stringent standards before they reach consumers. In the United States, the Food and Drug Administration (FDA) is renowned for its rigorous evaluation processes, conducting thorough reviews of drugs before granting approval for distribution. Similarly, the European Medicines Agency (EMA) serves as the regulatory authority for the European Union, overseeing the approval and supervision of medicines across member states.
Other countries have their own equivalents, such as Health Canada's Health Products and Food Branch (HPFB) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). These bodies conduct comprehensive assessments of drugs through clinical trials, inspections of manufacturing facilities, and ongoing surveillance of adverse events. Additionally, they establish guidelines for labeling, packaging, and advertising to ensure transparency and consumer safety.
Despite differing in structure and procedures, these regulatory bodies share a common goal of safeguarding public health by upholding stringent standards for the pharmaceutical industry. Collaboration and communication between these entities are essential for fostering global consistency in drug regulation and promoting access to safe and effective medications worldwide.
2. INTRODUCTION
We need regulation for maintaining safety, efficacy and
quality of medical product in every aspect. It is duty of
different agency appointed by government or
international committees to ensure and maintain SEQ of
product in every domestic as well as international
market.
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3. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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4. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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5. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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6. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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7. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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8. US
• USFDA
• United States Food and Drug Administration
Australian
• TGA
• Therapeutic Good Administration
UK
• MHRA
• Medicines and Healthcare Products Regulatory Agency
India
• CDSCO
• Central Drug Standard Control organization
International
member countries
• ICH
• International Conference for harmonisation
UN
Countries
• WHO
• World Health Organization
Countries and their regulatory bodies
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9. USFDA
FDA Regulates:-
• Biologics
• Product and manufacturing establishment licensing
• Safety of the nation's blood supply
• Research to establish product standards and develop
improved testing methods
• Cosmetics
• Safety
• Labelling
• Drugs
• Product approvals
• OTC and prescription drug labelling
• Drug manufacturing standards
• Foods
• Safety of all food products (except meat and poultry)
• Bottled water
• Medical Devices
• Premarket approval of new devices
• Manufacturing and performance standards
• Tracking reports of device malfunctioning and serious adverse
reaction
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10. FDA regulates:-
• Radiation-Emitting Electronic Products
• Radiation safety performance standards for microwave ovens,
television receivers, diagnostic x-ray equipment, cabinet x-
ray systems, laser products, ultrasonic therapy equipment,
mercury vapor lamps, and sunlamps accrediting and
inspecting mammography facilities
• Veterinary Products
• Livestock feeds
• Pet foods
• Veterinary drugs and devices
FDA does not regulates:-
• Advertising (federal trade commission)
• Alcohol (Department bureau of alcohol)
• Consumer Products (Consumer product safety commission)
• Drugs of Abuse (Drug enforcement administration)
• Health Insurance (Health care financing administration)
• Meat and Poultry (USDAFSIS)
• Pesticides (FDA, USDA and Environmental protection agency)
• Restaurants and grocery stores (ILRAGS)
• Water (FDA & EPA)
USFDA
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11. Tools of USFDA
GMP (good manufacturing practices)
GLP (good laborites practices)
GCP (good clinical practices)
CFR (code of federal regulation)
How drug come to market
USFDA
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Drug Discovery
Preclinical drug testing
Clinical phase I
Clinical phase II
Clinical phase III
FDA review and Approval
Country wise registration
Post marketed surveillances
Filling investigational
New Drug (IND)
Filling New Drug
Application (NDA)
New molecule
Modified drug
Change formulation
New action/use
Abbreviated New
Drug Application
(ANDA) not needed
clinal trail
18. CDSCO
Organization chart
Laborites
Postal office
Sub Zonal
office
Zonal
office
Head
quarters
• Testing
of drug
samples
• Validati
on of
test prot
ocols
• Report
submissi
on
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• Testing of
drug
samples
• Validatio
n of
test prot
ocols
• Report
submissi
on
• GMP audits
• Coordinatio
n with
state
• GMP
audits
• Coordi
nation
with
state
• New
drugs
• CLAA
• Import
• DTAB
• DCC
19. CDSCO
Responsibility of CDSCO:-
• New Drugs
• Clinical Trials in the country
• laying down the standards for Drugs
• control over the quality of imported Drugs
• Import registration and provide NOC for export
• Testing of drugs
• Oversight and market surveillance through inspectorate of
central over and above the state authority
CDSCO is divided into:-
1. State drug control authority
2. Zonal & Sub zonal drug control authority
1. State drug control authority function:-
• Licensing of drug manufacturing and sales establishments
• Licensing of drug testing laboratories.
• Approval of drug formulations for manufacture.
• Monitoring the quality of Drugs & Cosmetics, manufactured
respective state units and those marketed in the state.
• Investigation and prosecution in respect of contravention of legal
provisions.
• Administrative actions
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29. ICH
ICH regulate the quality, safety and efficacity of any medical products.
Q1A-Q1F Stability
Q2 Analytical validation
Q3A-Q3D Impurities
Q4A-Q4B Pharmacopoeias
Q5A-Q5E Quality of Biotechnological Products
Q6A-Q6B Specification
Q7 Good Manufacturing practices
Q8 Pharmaceutical Development
Q9 Quality risk management
Q10 Pharmaceutical quality system
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle management
Q13 Continuous Manufacturing of Drug Substances and
Drug Products
Q14 Analytical Procedure Development
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31. ICH
E1 Clinical safety for drugs used in long term treatment.
E2A-E2F Pharmacovigilance
E3 Clinical study reports
E4 Dose response studies
E5 Ethnic factors
E6 Good clinical practice
E7 Clinical trials in Geriatric Population
E8 General considerations for clinical trials
E9 Statistical Principals of clinical trials
E10 Choice of control group for clinical trials
E11-E11A Clinical trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation
E15 Definitions in Pharmacogenomics and Pharmacogenetics
E16 Qualifications for gnomic Biomarkers
E17 Multi-regional Clinical Trials
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32. M1 MedDRA Terminology
M2 Electronic Standards
M3 Nonclinical Safety Studies
M4 Common Technical Document
M5 Data elements & Standards for Drug dictionaries
M6 Gene Therapy
M7 Mutagenic Impurities
M8 Electronic common Technical Document
M9 Biopharmaceutics Classification System (BCS)-based Biowaivers
M10 Bioanalytical method validation and Study Sample Analysis
M11 Clinical electronic Structured Harmonised Protocol
M12 Drug Interaction Studies
M13 Bioequivalence for Immediate-Release Solid Dosage Form
M15 General Principles for model informed drug development
E18 Genomic sampling methodologies
E19 Safety data collection
E20 Adaptive Clinic Trials
E21 Inclusion of Pregnant and breastfeeding Individuals in Clinical
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33. Zone I
Zone II
Zone III
Zone IV
ICH
WORLD MAP ACCODING TO ZONES
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