The document discusses the roles of regulatory authorities and the FDA in drug development and approval. It explains that regulatory authorities establish standards for drug quality, safety and efficacy and monitor compliance, while the FDA is the US regulatory body responsible for protecting public health by ensuring the safety of drugs, medical devices and other products. The FDA reviews research and approves new products, ensures safety and proper labeling, works internationally to reduce regulation burden, and cooperates with experts and consumers.

1. THE ROLE AND REMIT OF REGULATORY
AUTHORITIES
AND FDA
DONEBY
A.SHEIK ABDULLA (117012101307)
M.SORNAMALYA (117011101310)
M.THASLEEMA PARVEEN(117011101310)
DRUG DISCOVERY AND DEVELOPMENT 10-03-20201
Course Teacher : P. MALA
Assistant professor
Department of Biotechnology
PMIST

2. THE ROLE AND REMIT OF REGULATORY AUTHORITIES
• Regulatory authorities are independent governmental body
established by legislative act in order to set standards.
• In a specific field of activity, or operations ,in the private
sector of the economy to enforce those standards.
• Regulatory agencies became popular means of promoting
fair trade and consumer protection as problems of commerce
and trade became complex , particularly in 20th century.
• The idea of the regulatory agency was first advanced in the
united states
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3. DRUG REGULATORY AUTHORITY
• The drug regulatory authorities(DRA) is the agency that
develops and implements most of the legislation and
regulation on pharmaceuticals.
• Its main task is to ensure the quality , efficacy and safety of
the drugs, and the accuracy of the product information.
• This is done by making certain rules that the manufacture,
procurement, import, export, distribution, supply and sale of
drugs, product promotion and advertising, and clinical trials
are carried out according to specified standards.
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4. Functions of regulatory authority
 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 available to public.
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5. • It is governed by both Centre and State
Governments under the Drugs & Cosmetics Act,
1940.
 MAIN BODIES:
• Ministry Of Health & Family Welfare (MHFW)
• Central Drug Standard Control
Organization(CDSCO)
• Indian Pharmacopoeia Commission (IPC)
• National Pharmaceutical Pricing Authority (NPPA)
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6. FDA
• The FDA represents the American regulatory
authority.
• Its mission statement defines its goal simply as
being to “protect public health”
• The FDA was found in 1930.
• The Food and Drug Administration (FDA or
USFDA) is an agency of the United States
Department of Health and Human Services.
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7. • 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 FDA has its headquarters at White Oak,
Maryland.
• The agency also has 223 field offices and 13
laboratories located throughout the 50 states, the
United States Virgin Islands, and Puerto Rico.
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8. DRUG DISCOVERY AND DEVELOPMENT 10-03-2020
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9. FDA- Organizations
• The Office of the Commissioner (OC)
• The Center for Drug Evaluation and Research (CDER)
• The Center for Biologics Evaluation and Research
(CBER)
• The Center for Food Safety and Applied Nutrition
(CFSAN)
• The Center for Devices and Radiological Health (CDRH)
• The Center for Veterinary Medicine (CVM)
• The National Center for Toxicological Research (NCTR)
• The Office of Regulatory Affairs (ORA)
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11. FDA CENTERS
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12. Responsibilities of US-FDA
FDA is responsible for protecting the public
health by assuring the
safety
Efficacy and
Security of human and veterinary drugs
Biological products
Medical devices
Us nation’s food supply
Cosmetics and Products that emit radiation
By helping to speed innovations that make medicines more
 Safer and
 More affordable
 Effective
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13. By helping the public get the
 Accurate
 Science-based information they need to use
medicines &
 Foods to maintain and improve their health.
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14. Functions of US-FDA FDA has 4 roles:
o To promote health by reviewing research and
approving new products.
o To ensure foods and drugs are safe and
properly labeled.
o To work with other nations to “reduce the
burden of regulation”.
o To cooperate with scientific experts and
consumers to effectively carry out these
obligations.
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15. US-FDA Regulates
• Foods, except for most meat and poultry products, which are
regulated by the U.S. Department of Agriculture.
• Food additives
• Infant formulas ,Dietary supplements
• Human drugs
• Vaccines, blood products, and other biologics
• Medical devices, from simple items like tongue depressors, to
complex technologies such as heart pacemakers. Electronic
products that give off radiation, such as microwave ovens and X
ray equipment.
• Cosmetics.
• Feed, drugs, and devices used in pets, farm animals, and other
animals.
• Tobacco products.
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16. US-FDA Doesn't regulates
• Advertising (except for prescription drugs, medical
devices, and tobacco products).
• Alcoholic beverages
• Some consumer products, such as paint, child-resistant
packages, baby toys, and household appliances (except
for those that give off radiation)
• Illegal drugs of abuse, such as heroin and marijuana.
• Health insurance.
• Meat and poultry (except for game meats, such as
venison, ostrich, and snake).
• Restaurants and grocery stores.
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17. References:
• Biopharmaceuticals - GARY WALSH
• COURTESY – Google images
• FDA(https://fda.maharashtra.gov.in/Aboutus.a
spx )
• NPPA ( http://www.nppaindia.nic.in/)
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