The World Health Organization (WHO) and the US Food and Drug Administration (FDA) are introduced. WHO is a specialized agency of the UN concerned with international public health, established in 1948. The FDA is a US federal agency that regulates food, drugs, medical devices, and tobacco. Both organizations work to protect public health by establishing standards and guidelines, providing technical support to countries, and regulating products.

1. Overview Of WHO and
FDA

2. Presented by:
Group A-7
QAU Islamabad

4. INTRODUCTION
 The World Health Organization (WHO) is a
specialized agency of the United Nations (UN) that is
concerned with international public health.
 Established on: 7 April 1948
 Headquartered in: Geneva,
Switzerland.
 The constitution of the WHO had
been signed by 61 countries on 22 July 1946.

5.  The WHO is responsible for:
 The World Health Report, a leading international
publication on health.
 The Worldwide World Health Survey
 World Health Day (7 April of every year).
 The head of WHO is
Margaret Chan.

6. HISTORY
 First International Sanitary
Conference (1851)
 Pan American Sanitary Bureau (1902)
 The Health organization of the league
of nations (1923)
 UNRRA (1943)
 Formation of WHO (1945)
 International Health Conference
(1946)

7. HEALTH ACCORDING
TO WHO
“Health is a state of
complete physical,
mental and social well
being and not merely
the absence or
disease of infirmity”

8. WHO REGIONAL ORGANIZATION

9. REGIONS HEADQUARTERS
Africa
Brazzaville , Republic of
Congo
Europe Denmark
South-East Asia New Delhi, India
Eastern Mediterranean Egypt
Western Pacific Manila, Philippines.
The Americas Washington , USA.

10. MEMBERSHIP
 Open to all countries.
 All countries that are part of UN are also members of
WHO with the exception of Switzerland as an
example of a country which is part of WHO but not
the UN.

11. PRIORITIES
Current priorities includes:
 Communicable diseases
 Non-communicable diseases
 Substance abuse
 Development and aging
 Nutrition, food security and healthy eating
 Driving the development of reporting, publications and
networking.

12. OBJECTIVES
“The attainment of highest level of
health by all people”.
“Attainment by all people
of the world a level of
health that will permit
them to leave a socially
and economically
productive life.”

13. RESPONSIBILITIES
 Global Health Matters
 Shaping the Health research agenda (Schedule)
 Setting norms and standards
 Articulating evidence based policy option
 Providing technical support to countries
 Monitoring and assessing health trends

14. WHO’S WORK
 Family health
 Environmental Health
 Health statistics
 Bio-medical research
 Health literature and information
 Prevention and control of specific diseases
 Development of comprehensive health services

15. GLOBAL HEALTH
CLUSTER
 “A group of agencies, organizations and/or
institutions interconnected by their respective
mandates, that works together towards common
objectives.”

16. •In 2005, the UN Inter-Agency Standing
Committee (IASC) designated WHO as the
lead agency for the Global Health Cluster.
•Over 32 partners are working together in
the Global Health Cluster, under the
leadership of WHO.

17. AIMS
Aim of cluster is to strengthen system-
wide preparedness and technical capacity
to respond to humanitarian emergencies
by ensuring that there is predictable
leadership and by enhancing the
accountability and transparency of
humanitarian response.

18. The Global Health Cluster aims to ensure sufficient
capacity in :
 surge
 Advocacy
 resource mobilization
 information management
 normative guidance and tools
 development of the capacities of national
stakeholders

19. STRUCTURE

20. WHO GUIDELINES
Sampling
guidelines
Stability
guidelines
Production
guidelines
Quality
control
guidelines
Distribution

21. ROLE OF PUBLIC HEALTH IN
COMMUNICABLE DISEASES
 Regional Health Authorities and other health cares such as
First Nations Inuit Health (FNIH) are responsible for the
provision of direct health services.
 Regional Medical Officers of Health are the first resource
when information is sought by health practitioners
regarding the management and prevention of
communicable diseases.

22. ROLE OF PUBLIC HEALTH IN MENTAL
HEALTH
 Identify risk factors, increase awareness
about mental disorders and the
effectiveness of treatment, eliminate
health problems and improve access to
mental health services for all persons.
 CDC is playing its role in
safeguarding mental health by
supporting the efforts of other health
agencies, i.e the Substance Abuse and
Mental Health Services Administration
and the National Institute of Mental
Health.

23. LIFE COURSE
Life course is defined as……
“A sequence of socially defined
events and roles that the
individual enacts over time“
Life course perspective
elaborates the importance of
time, context, process, and
meaning on human development
and family life

24. PRINCIPLE OF LIFE COURSE
Several fundamental principles characterize the life course
approach. They include:
(1) Socio-historical and geographical location
(2) Timing of lives
(3) Heterogeneity or variability
(4) “Linked lives" and social ties to others
(5) Human agency and personal control
(6) How the past shapes the future

25. LIFE STYLE
Life style is defined as………
“A set of attitudes, habits,
or possessions associated
with a particular person or
group is life style”
A way of living of individuals, families
(household), and societies, which
they manifest in coping with their
physical, psychological, social,
and economic environments on a day-
to-day basis.

26. LIFE STYLE DISEASES
Diseases include..
 Alzheimer's disease
 Arthritis
 Atherosclerosis
 Asthma
 Chronic liver disease
“ Diseases of
longevity”
Disease that appear to
increase in frequency as
countries become more
industrialized and
people live longer.

27. • Heart disease
• Metabolic syndrome
• Chronic renal failure
• Osteoporosis
• Stroke
• Depression
• Obesity

28. CAUSES OF LIFE STYLE DISEASES
According to World Health
Organization
smoking, alcohol abuse and
high-fat diets have sparked a
'slow-moving public health
disaster' because they can cause
non-communicable diseases
(NCDs) like cardiovascular
conditions, diabetes and lung
disease.

29. REDUCING MORBIDITY AND MORTALITY
 WHO Department of Health Statistics and
Informatics is supporting countries to
strengthen their routine health information
and civil registration systems.
 WHO is working to
reduce morbidity and mortality and improve
health during key stages of life, including
pregnancy, childbirth, the neonatal
period, childhood and adolescence, and
improve reproductive health and promote
active and healthy aging for all individuals.

30. LIFE COURSE AND LIFE STYLE
AIMS OF WHO
 To reduce morbidity and mortality
 It helps to prevent or reduce risk factors for "health
conditions associated with use of tobacco,
alcohol, drugs and other psychoactive substances,
unhealthy diets and physical inactivity
 WHO works to improve nutrition, food
safety and food security

31. PARTNERSHIP WITH WORLD BANK
World Bank
The World Bank is an international
financial institution..
The WHO along with the World
Bank constitute the core team
responsible for administering
the International Health
Partnership (IHP+).

32. Partners work together to put
international principles for aid
effectiveness and development
cooperation into practice in the
health sector.
 US$320 million were amounted (in
2002) to combating HIV/AIDS, TB,
malaria and other communicable
diseases.

33. AIMS AND OBJECTIVES OF WORLD
BANK
 Improve the health, nutrition and population outcomes of
poor and protect the population from effects of illness,
malnutrition and high fertility.
 Enhance the performance of health systems by promoting
access to preventive and curative health services effective,
well managed and responsive to clients.
 Finance health service by mobilizing adequate levels of
resources and maintaining effective control over public and
private expenditure.

34. ROLE OF WHO IN MEDICINAL REGULATION
The role of WHO in the area of medicines
regulatory support is two-fold.
 One aspect relates to the development of
internationally recognized norms,
standards and guidelines.
 The second aspect relates to providing
o Guidance
o Technical assistance
o Training in order to enable countries to
regulate environment and medicine

35. DRUGS ABUSE
Abused drugs include
 Amphetamines
 Cocaine
 Heroin
 Inhalants
 Marijuana
 Prescription drugs
Drug abuse cause major social problems i.e., violence,
stress, and child abuse, homelessness, crime. It
harms unborn babies and destroys families.

36. WHO OFFERED THE FOLLOWING
RECOMMENDATIONS:
•Countries should work toward developing policies and laws
that decriminalize injection and other use of drugs and,
thereby, reduce incarceration.
•Countries should work toward developing policies and laws
that decriminalize the use of clean needles and syringes (and
that permit NSPs [needle and syringe programs]) and that
legalize OST [opioid substitution therapy] for people who are
opioid-dependent.

37. PUBLIC HEALTH EDUCATION AND
ACTION
Official global public health campaigns marked by WHO are
 World Tuberculosis Day
 World Immunization Week
 World Malaria Day
 World No Tobacco Day
 World Blood Donor Day
 World Hepatitis Day
 World AIDS Day.

38. ROLE OF WHO IN THE DEVELOPMENT OF
HEALTH SECTORS IN PAKISTAN
According to the WHO guidelines, Pakistan
launched multiple programs that included malaria
control program an expanded program of
immunization (EPI), family planning program etc. All
of these programs are monitored by the national
institute of health

39.  In Pakistan establishment of WHO’s country office
took place in January 1960.
 During the sixties… establishment of rural health
centers (RHC)
 Seventies was the decade of primary health care
(PHC), This covers the aspects like reproductive
health, vaccination, health education, diarrhea
control and all the components of PHC accessible
to community easily.

40.  Efforts of WHO and Pakistan collectively
resulted in eradication of small pox in 1974, and
alleviation of guinea worm diseases in 1993.
 Another successful program was the recognition
of tuberculosis as a national emergency in 2001
and providing DOTS to the population suffering
from tuberculosis.

42. INTRODUCTION
The Food and Drug
Administration (FDA or USFDA) is
a federal agency of the United States
Department of Health and Human
Services. The FDA was empowered by
the United States Congress to enforce the
Federal Food, Drug, and Cosmetic Act
 FDA also enforces other laws, such as
Public Health Service Act and
associated regulations, many of which are
not directly related to food or drugs.

43. HEADQUARTERS
 The FDA has its headquarters at
White Oak, Maryland. The
agency also has 223 field offices
and 13 laboratories located
throughout the 50 states
 In 2008, the FDA started
opening offices in foreign
countries, including China ,
India , Chile , Belgium and the
United Kingdom.

44. BASIC HISTORY OF THE FDA
 Food and Drugs Act of 1906 laid the foundation for the
modern food and drug law
 Safety of food additives was previously tested by the
“Poison Squad”
 Later, it was discovered that the drug Sulfanilamide
contained a poison which killed 107 people
 The previous law did not require testing for drug safety
before putting them on the market.
 The next year Congress passed the Federal Food, Drug,
and Cosmetic Law.
 FDA combines law and science to protect consumers

45. Center for Veterinary
Devices
Food and Drug
Administration
Center for Biologics
Evaluation and Research
Center for Devices and
Radiological Health
National Center for
Toxicological Research
Center for Food Safety and
Applied Nutrition
Center for Drug Evaluation
and Research
FDA STRUCTURE / ORGANIZATION
45

46. WHO MAKES UP THE FDA?
The FDA consists of
employees drawn from a
wealth of science and public
health professions
biologists, physicians,
chemists , biomedical
engineers, toxicologists,
pharmacologists,
veterinarians, and
specialists in the public
health education and
communication

47. WHAT FDA DO ?
FDA is responsible for protecting the
public health by assuring the safety, efficacy
and security of
 human and veterinary drugs
 biological products
 medical devices
 food supply
 cosmetics
 products that emit radiation

48. FDA is also responsible for
advancing the public
health by helping to speed
innovations that make
medicines more effective,
safer, and more affordable
and by helping the public
get the accurate, science-
based information they
need to use medicines and
foods to maintain and
improve their health.

49. It is responsible for
regulating the
manufacturing,
marketing and
distribution of
tobacco products
to protect the
public health and
to reduce tobacco
use by minors.

50. WHAT DOES FDA REGULATE?
 The scope of FDA’s
regulatory authority is
very broad.
 In general, FDA
regulates:
Foods including:
 dietary supplements
 bottled water
 food additives
 infant formulas
Drugs
 prescription
drugs (both
brand-name and
generic)
 non-prescription
(over-the-counter
drugs)

51. FOODS PRODUCTS
Center for Food Safety and Applied
Nutrition
 Monitoring of food supply
 Approval of new food additives
 Monitors dietary supplements

52. DRUGS
 The Center for Drug Evaluation and
Research involves regulation of three main
drug product types:
New drugs
Generic drugs
Over-the-counter drugs
 It covers more than just medicines.
E.g. fluoride toothpaste, antiperspirants,
dandruff shampoos and sunscreens are all
considered "drugs."

53. DRUGS
New drugs
New drugs receive extensive scrutiny before FDA
approval in a process called a New Drug
Application (NDA).New drugs are available only by
prescription by default.
Generic drugs
Generic drugs are chemical equivalents of name-brand
Approval is done by Food and Drug Administration
(FDA)
Over-the-counter (OTC) drugs
FDA has a list of approximately 800 approved
ingredients that are combined in various ways to create
more than 100,000 OTC drug products.

54. FDA REGULATES
Cosmetics including:
 color additives
 skin moisturizers and
cleansers
 nail polish and
perfume
Biologics:
• vaccines
• blood and blood products
• cellular and gene therapy
products
• allergenic

55. SAFE BLOOD SUPPLY AND VACCINE
DEVELOPMENT
Biologics Evaluation and Research branch
works on this..
Aims
 Ensures safety of blood products supply
and regulation of vaccine products
• Addresses areas such as emergency
operations, response to emerging
diseases, and updating of regulations.
 Vaccine approval

56. COSMETICS

57. FDA intervene when necessary to protect the public but
in general does not require pre-market approval or
testing.
What Can FDA Do if a Cosmetic Is Not Safe?
To prevent further shipment of a cosmetic that does not
comply with the law, FDA may
 ask a federal court to issue an injunction
 Request to seize the products
 Initiate criminal action
 Refuse entry of an imported cosmetic
 Request that a company recall a product

58. CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH DEALS WITH…..
Medical Devices:
 Simple items like tongue depressors
 Complex technologies such as heart pacemakers
 Surgical implants and prosthetics
Electronic Products that give off radiations:
 X-ray equipment
 Laser products
 Sunlamps

59. FDA ASLO REGULATES…..
Veterinary Products including:
 livestock feeds
 veterinary drugs and devices
Tobacco Products:
 cigarette tobacco
 smokeless tobacco

60. DRUG FROM INVENTION TO MARKET
The process of drug approval is
governed by Food and Drug
Administration (FDA) The FDA
requires the following sequence is
involved.
Preclinical Testing:
Test conducted by pharmaceutical
companies.
Invitro and in vivo studies to check
effect and safety
These tests take on the average 3 1/2
years.

61. INVESTIGATIONAL NEW DRUG
APPLICATION (IND):
Testing the drug in people.
The IND becomes effective if the FDA does not disapprove it
within 30 days.
IND must include the following information:
 Results of previous experiments
 Chemical structure of the compound
 How it works in the body
 Toxicities
 Manufacturing of compound

62. PHASE I CLINICAL TRIALS:
These are first tests of a drug under development in
healthy volunteers.
Studies involve about 20 to 80 volunteers.
Tests determine a drug's safety profile, including the safe
dosage ,absorbtion,distribution,metabolism and excretion
and duration of its action.
Phase I trials take on the average 1 year.

63. PHASE II CLINICAL
TRIALS:
Studies that are done in patients with the
disease for which the drug is intended.
This phase is designed to identify
minimum and maximum doses.
Trials involve 100 to 300 volunteer patients
and are controlled in design.
Phase II typically takes about 2 years.

64. PHASE III CLINICAL TRIALS:
Large randomized trials that are submitted to the FDA in order to
obtain approval of a drug.
Check effectiveness as well as adverse effects of the new drug
Usually involve 1,000 to 3,000 patients in clinics and hospitals
Patients are asked a list of possible side effects, derived from what
was observed in phase II studies.
Patients are free to report any other side effects that occur while they
are on the new drug or the placebo.
Phase III takes on the average 3 years.

65. NEW DRUG APPLICATION (NDA):
Following the Phase III Clinical Trials, the drug
manufacturer analyzes all the data from the studies and
files an NDA with the FDA
The NDA contains all of the data gathered to date about
the drug.
The average NDA review time for new drugs approved in
1992 was close to 30 months

66. PHASE IV STUDIES:
Phase IV is any organized collection of data from
patients who are taking a drug that has already received
approval from the FDA.
In Phase IV studies, patients may report other
symptoms.
Phase IV studies are commonly called "post-marketing
studies."

67. RESEARCH AREAS OF FDA
FDA invests significant resources in
research to:
 Further scientific knowledge about
potential food hazards
 Expand on best safety practices
 Genetically Engineered Plants for
Food & Feed

68. BIOLOGICAL PRODUCTS
Allergenics Research:
Immunobiochemistry
 Improving Safety and Potency Testing of Allergen Extracts
 Assessing the Mechanism of Immunotherapy for Allergy
and Allergic Asthma: Effect of Viral Respiratory Infections
on Pathogenesis and Clinical Course of Asthma and
Allergy

69. CONT…
Cellular Hematology
 Studies on Safety and Efficacy of
Platelets and Other Transfused Blood
Products
 Blood Safety: Developing Methods to
Reduce Infectious Agents in Blood
and Related Products and Identifying
Biomarkers of Stored Blood Cells
 Investigation of Potential Toxic
Effects of Engineered Nanoparticles
and Biologic Microparticles in Blood
BLOOD RESEARCH

70. CONT…
Tissue Therapy
 Developing Ways to Measure Safety and Efficacy for
Tissue-engineered Products
 Predicting the Safety and Efficacy of Cell and Tissue
Products Used for Repair of Damaged Tissue and
Structures through Cell Growth and Maturation Pathways
TISSUE RESEARCH

71. RESPIRATORY & SPECIAL
PATHOGENS:
 Improving Vaccine Manufacturing for Bacterial
Respiratory Pathogens
 Developing and Evaluating Animal Models to study
Safety and Efficacy of Vaccines Against Anthrax,
Staphylococcal Infections, and Pertussis
 Biomarkers of Vaccine Safety and Efficacy for
Diphtheria Vaccines

72. DNA and Hepatitis Viruses:
 Developing New Methods to
Measure the Efficacy, Safety and
Potency of Preventive and
Therapeutic Vaccines Against
Hepatitis Viruses
 DNA Virus Vaccines and Vectors

73. EVOLUTION AND FUTURE OF FDA

74.  This was overview of the history and
evolution of FDA human drug regulation.
 It is evident that past, present, and future
legislative actions serve to promote and
protect public health by providing safe and
effective drugs

75.  Advertising (except for prescription drugs, medical
 devices, and tobacco products).
 Alcoholic beverages
 Some consumer products
 Illegal drugs of abuse, such as heroin and marijuana.
 health insurance.
 Meat and poultry (except for game meats, such as
ostrich, and snake).
 Restaurants and grocery stores.
75
FDA DOES NOT REGULATE

76. REFERENCES
FDA Website www.fda.gov
Wikipedia Website www.wikipedia.com