Regulatory Aspects Of Drugs And
Cosmetics

TOPIC: USA & CANADA

DEPARTMENT OF PHARMACEUTICAL REGULATORY AFFAIRS

WWW.DULOMIX.COM 1

CONTENTS
1. Organization structure and functions of FDA

2. Federal register and code of federal regulations (CFR)

3. History and evolution of united states Federal, Food, Drug, and Cosmetics Act
(FFDCA)

WWW.DULOMIX.COM 2

ORGANIZATION STRUCTURE OF FDA

WWW.DULOMIX.COM 3

WWW.DULOMIX.COM 4

WWW.DULOMIX.COM 5

WWW.DULOMIX.COM 6

WWW.DULOMIX.COM 7

WWW.DULOMIX.COM 8

WWW.DULOMIX.COM 9

WWW.DULOMIX.COM 10

WWW.DULOMIX.COM 11

WWW.DULOMIX.COM 12

Organization Structure Of CANADA

1. President
Sony Perron

2. Executive Vice-President
Scott Jones

•Assistant Deputy Minister, Chief Financial Officer
Samantha Hazen

•Assistant Deputy Minister, Enterprise IT Procurement and Corporate Services
Robert Ianiro

•Assistant Deputy Minister, Strategy and Engagement Branch
Paule Labbé

•Assistant Deputy Minister, Networks and Security
Patrice Nadeau

WWW.DULOMIX.COM 13

•Associate Assistant Deputy Minister, Networks and Security
Nutan Behki

• Acting Assistant Deputy Minister, Digital Services
Scott Davis

•Assistant Deputy Minister, Data Centre Services
Jacquie Manchevsky

•Senior Assistant Deputy Minister, Project Management and Delivery
Louis-Paul Normand

•Senior Assistant Deputy Minister, Operations Management
Greg McKay

•Senior Assistant Deputy Minister, Client Service Delivery and Management—Citizen and
Business
Ken Canam

•Assistant Deputy Minister, Client Service Delivery and Management—Citizen and Business
Kristina Casey

WWW.DULOMIX.COM 14

•Assistant Deputy Minister, Client Service Delivery and Management—National Defence and
Policing
Brendan Dunne

•Assistant Deputy Minister, Client Service Delivery and Management—Digital Government and
Science
José Gendron

•Chief Technology Officer
Matt Davies

•Deputy Chief Technology Officer
Shannon Archibald

•Assistant Deputy Minister, Next Generation HR and Pay
Shereen Benzvy Miller

•Chief Audit and Evaluation Executive
Begonia Lojk

WWW.DULOMIX.COM 15

Functions Of FDA

FDA is responsible for

•Protecting the public health by assuring that foods (except for meat from livestock, poultry and
some egg products which are regulated by the U.S. Department of Agriculture) are safe,
wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines
and other biological products and medical devices intended for human use are safe and effective

•Protecting the public from electronic product radiation

•Assuring cosmetics and dietary supplements are safe and properly labeled

•Regulating tobacco products

•Advancing the public health by helping to speed product innovations

FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam,
the Virgin Islands, American Samoa, and other U.S. territories and possessions.

WWW.DULOMIX.COM 16

History And Evolution Of FFDCA
➢In united states federal food, drug and cosmetic Act is a set of law passed by
congress in 1938 giving of food, drugs, and cosmetics.

➢It replaced the earlier Pure food and drug act of 1906 due to elixir
sulphanilamide disaster.

➢1938 Act continued the information provision requirements of the 1906 act.

➢The classification “misbranded” was expanded example, and now included any
drug whose label failed to identify and quantify the precise ingredients, to list
effects and possible side effects, and to give directions and cautionary
information.

➢1938 act also expanded the FDA’s powers over medical devices.

WWW.DULOMIX.COM 17

Brief History of FD&C Act

➢ 1906 Food and Drug Act
• Prohibited misbranding and adulteration of foods and drugs

➢ 1938 Federal Food Drug and Cosmetic act
• preclearance of drugs for safety

➢ 1951 Durham- Humphrey Amendment
• Separated prescription drugs from over the counter
• Allowed FDA to regulated prescription drug labelling

➢ 1962 Kefauver Harris Amendment
• Required drugs prove efficacy (in addition to safety)

WWW.DULOMIX.COM 18

Reason For Implemented New Act

1937 : sulfanilamide crisis

November 16, 1937 : A senate resolution directs the U.S. Department Of
Agriculture to give a full accounting of the “Elixir Sulfanilamide” tragedy.

▪ The drug, containing a poisonous solvent (ethylene glycol/propylene
glycol mix up),was not safety tested and has killed 107 persons, many of
them children.

▪ The incident made congress to pass the Federal Food, Drug And

Cosmetic Act, which includes stronger drug safety requirements.

WWW.DULOMIX.COM 19