1. Presented by :
PARTH
M.Pharm (sem:2)
Department of Quality Assurance
K.B.Raval College of Pharmacy
Enroll. no. :11
Guided By:
Pranit Patel
Jan 25, 2013 1
2. STANDARD INSTITUTE:
BSS: British Standard Specification
ISO: International Organization for Standardization
ASTM: American Society for Testing and Materials
ISI: Indian Standard Institution
REGULATORY AUTHORITY:
US FDA: United States Food and Drug Administration
MHRA: The Medical Health and Regulatory Agency ( MCA + MDA)
MDA: The Medical Devices Agency
UK MCA: The Medicine Control agency
TGA: Therapeutic Goods Administration
WHO: World Health Organization
Jan 25, 2013 2
4. USFDA is a government agency of the United States,
Department of Health and Human Services.
The FDA is responsible for regulating and supervising the
safety of
o Foods
o Tobacco products
o Dietary supplements
o Prescription and non-prescription medications
o Vaccines
o Biopharmaceuticals
o Blood transfusions
o medical devices
o Electro magnetic radiation emitting devices
o veterinary products
o cosmetics
Jan 25, 2013 4
5. Scope
• To provide safe and effective Medicine, Biological and
Medicinal devices.
• To provide safe, effective and sanitary Food.
• To provide truthful and informative label.
• To provide safe and effective Animal Drugs.
• For facilitating safe consumer and Medical Radiation
products.
Jan 25, 2013 5
6. Definition by the Food and Drug Administration
“Medical Device”
• A device is:
• "an instrument, apparatus, implement, machine, implant, in
vitro reagent, or other similar or related article, including a
component part, or accessory which is:
-recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them,
-intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals
Jan 25, 2013 6
7. Objectives:
Better consumer information
Post marketing safety
New product review
Keep watch on safe manufacturing and handling
Monitoring for new risk
Standardization and regulation
Enforcement and corrective problem
Jan 25, 2013 7
8. Regulatory Programs
The programs for safety regulation vary widely by the
type of product, its potential risks, and the regulatory
powers granted to the agency.
For example, the FDA regulates almost every part of
prescription drugs, including testing, manufacturing,
labeling, advertising, marketing, efficacy and safety,
FDA regulation of cosmetics is focused primarily on
labeling and safety.
Jan 25, 2013 8
9. Regulatory Programs
(continue)
1. Food and dietary supplements
• The Center for Food Safety and Applied Nutrition is
the branch of the FDA which is responsible for
ensuring the safety and accurate labeling of nearly
all food products in the United States.
2. Drugs
• The Center for Drug Evaluation and Research has
different requirements for the three main types of
drug products:
• a) new drugs, b) generic drugs and c) over-the-
counter drugs.
Jan 25, 2013 9
10. a) New drugs
• New drugs receive extensive scrutiny before FDA
approval in a process called a New Drug Application.
• New drugs are available only by prescription by
default. A change to Over the Counter (OTC) status is
a separate process and the drug must be approved
through an NDA first.
Jan 25, 2013 10
11. a) New drugs (cont.)
Advertising and promotion
• The drug advertising regulation contains two key
requirements. Under most circumstances, a company may
only advertise a drug for the specific indication or
medical use for which it was approved.
• Also, an advertisement must contain "fair balance"
between the benefits and risks of a drug.
Jan 25, 2013 11
12. a) New drugs (cont.)
Post market safety surveillance
• After approval of an NDA, the sponsor must review
and report to the FDA every patient adverse drug
experience of which it learns.
• Unexpected serious and fatal adverse drug events
must be reported within 15 days; other events on a
quarterly basis.
Jan 25, 2013 12
13. b) Generic drugs
• Generic drugs are chemical equivalents of name-
brand drugs whose patents have expired.
• Generally they are less expensive than their name
brand counterparts, are manufactured and marketed
by other companies and, in the 1990s, accounted for
about a third of all prescriptions written in the United
States.
Jan 25, 2013 13
14. c) Over-the-counter drugs
• Over-the-counter (OTC) drugs are drugs and
combinations that do not require a doctor's
prescription.
• The FDA has a list of approximately 800 approved
ingredients that are combined in various ways to
create more than 1,00,000 OTC drug products.
Jan 25, 2013 14
15. 3) Vaccines, blood and tissue products, and
biotechnology
• The Center for Biologics Evaluation and Research is
the branch of the FDA responsible for ensuring the
safety and efficacy of biological therapeutic agents.
• These include blood and blood products, vaccines,
allergenic, cell and tissue-based products, and gene
therapy products.
Jan 25, 2013 15
16. 4) Medical and radiation-emitting devices
• The Center for Devices and Radiological Health
(CDRH) is the branch of the FDA responsible for the
premarket approval of all medical devices, as well as
overseeing the manufacturing, performance and
safety of these devices.
• CDRH regulatory powers include the authority to
require certain technical reports from the
manufacturers or importers of regulated products, to
require that radiation-emitting products meet
mandatory safety performance standards.
Jan 25, 2013 16
17. 4) Cosmetics
• Cosmetics are regulated by the Center for Food
Safety and Applied Nutrition, the same branch of the
FDA that regulates food.
• Cosmetic products are not generally subject to pre-
market approval by the FDA unless they make
"structure or function claims" which make them into
drugs
Jan 25, 2013 17
18. 5) Veterinary products
• The Center for Veterinary Medicine (CVM) is the branch
of the FDA which regulates food, food additives, and
drugs that are given to animals, including food animals
and pets.
• CVM does not regulate vaccines for animals; these are
handled by the United States Department of Agriculture
Jan 25, 2013 18
19. Year Advancement in FDA
1820 U.S Pharmacopoeia
1897 Drug importation Act
1883 Bureau of Chemistry’s Food adulteration Studies
1902 The Biologics Control Act
1906 The original Food and Drugs Act is passed
1933 Complete revision of the obsolete 1906 Food and Drugs Act.
1907 Certified Color Regulations
1937 Elixir of Sulfanilamide, containing the poisonous solvent diethylene
glycol, kills 107 persons,
1939 First Food Standards
1949 Guidence to industry On procedure for the appraisal of toxicity of
chemical in food.
1954 Radiological examination of food
1966 Child protection act
1971 National centre for Toxicological research
1976 Medical device amendments
1982 Temper resistant packaging regulations
1994 Dietary supplement health and education act
Jan 25, 2013 19
2004 Food allergy labeling and consumer protection act
20. FDA Components:
Sr. Componen Full Form Regulates
no t
A CBER Center For Biologics Biological Products.
Evaluation And
Research
B CDRH Center For Devices Safety and Effectiveness of
And Radiologic Health New medical Devices Before
they are Marketed.
C CDER Center For Drug Assuring Prescription and OTC
Evaluation And Drugs are Safe and Effective.
Research
D CSFAN Center For Food Food Supply is Safe, Sanitary,
Safety And Applied Wholesome and Honestly
Nutrition labeled.
E CVM Center For Vaterinary Assure that Animal Food
Medicines Products are Safe
F NCTR National Center For Human Toxicology
Jan 25, 2013 Toxicological Research 20
21. FDA REGULATES
• FDA is the federal agency responsible for ensuring that
foods are safe, wholesome and sanitary; human and
veterinary drugs, biological products, and medical
devices are safe and effective; cosmetics are safe; and
electronic products that emit radiation are safe.
• FDA also ensures that these products are honestly,
accurately and informatively represented to the public.
Jan 25, 2013 21
22. 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
labeling
Drugs
product approvals
OTC and prescription drug labeling
drug manufacturing standards
Jan 25, 2013 22
23. Foods
labeling
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 reactions
Jan 25, 2013 23
24. 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.
Veterinary Products
livestock feeds
pet foods
veterinary drugs and devices
Jan 25, 2013 24
25. What FDA Does?
Responsible for advancing the public health
To speed innovations that make medicines and foods
more effective, safer, and more affordable
Helping the public get the accurate, science-based
information they need to use medicines and foods to
improve their health.
Jan 25, 2013 25
27. UK MCA
Introduction
The Medical Health and Regulatory Agency (MHRA) was
set up in April 2003 from a merger of the Medicines Control
Agency (MCA) and the Medical Devices Agency(MDA).
The MHRA is the government agency which is responsible
for ensuring that medicines and medical devices work, and
are acceptably safe.
The MHRA is an executive agency of the Department of
Health.
Jan 25, 2013 27
28. Mission
To enhance and protect the health of the public by
ensuring that medicines and medical devices work, and
are acceptably safe.
Values
To fulfill this mission they will act with:
Integrity
Openness
Responsiveness
Timeliness
Professionalism
Impartiality
Consistency
Jan 25, 2013 28
29. AIMS OF UK MCA
Protecting public health through regulation, with
acceptable benefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these
products to understand their risks and benefits.
Improving public health by encouraging and facilitating
developments in products that will benefit people.
Jan 25, 2013 29
30. OBJECTIVE OF UK MCA
Protect public health through ensuring that the
products meet required standards that are safe.
To communicate healthcare professionals, patients
and the public through the provision of accurate,
timely and authoritative information.
Influence the regulatory framework through use of
European and International organizations.
Run an organization with a skilled and equipped
workforce that improve standard.
Jan 25, 2013 30
31. UK MCA's Structure
The MHRA's main activities are supported by various
divisions which are responsible for information
management, providing executive support services,
human resources and finance.
1)The Agency Board: Made up of a non-executive
Chairman, six non-executive members and the
Agency's Chief Executive Officer.
2)The Chief Executive: Responsible for service delivery
and resources.
3)The Executive Board: Consisting of the Agency's
directors, takes overall responsibility for day-to-day
management,
4)The Risk and Audit Committee:
Jan 25, 2013 31
32. UK MCA's Activities:
Assessing the safety, quality and efficacy of
medicines, and authorizing their sale or supply in the
UK for human use.
Operating a positive compliance programmed for
medical devices.
Regulating clinical trials of medicines and medical
devices.
Jan 25, 2013 32
33. UK MCA's Activities(continue):
Monitoring and ensuring compliance with legal
obligations relating to medicines and medical devices
through inspection, taking enforcement action where
necessary
Promoting good practice in the safe use of medicines and
medical devices;
Managing the General Practice Research Database
(GPRD) and the British Pharmacopoeia (BP) and
contributing to the development of standards for medical
devices
Jan 25, 2013 33
34. UK MCA's Activities(continue):
Offering scientific, technical and regulatory advice on
medicines and medical devices;
Providing the public with authoritative information to
enable informed dialogue on treatment choices.
Jan 25, 2013 34
35. What UK MCA regulate?
It regulates a wide range of materials;
Medicines
Medical devices
Blood
Therapeutic products/services that are derived from
tissue engineering.
Jan 25, 2013 35
36. OTHER REGULATORY AGENCIES
CONTROLLED BY UK MCA
1) National Patient Safety Agency (NPSA)
2) National Reporting and Learning Agency (NPLA)
3) National Clinical Assessment Service (NCAS)
4) National Research Ethics Service (NRES)
5) Care Quality Commission (CQC)
6) National Institute for Health and Clinical
Excellence (NICE)
Jan 25, 2013 36
38. TGA (Therapeutic Goods
Administration)
The Therapeutic Goods Administration (TGA) is a
unit of the Australian Government Department of
Health and Ageing and is responsible for
administering the provisions of the legislation.
The TGA carries out a range of assessment and
monitoring activities to ensure therapeutic goods
available in Australia are of an acceptable standard.
Jan 25, 2013 38
39. Purpose:
This guideline provides a general introduction to the
regulatory process for medicines in Australia. It is
designed to help you determine whether your product
is likely to be regulated by the TGA.
Jan 25, 2013 39
40. What is a therapeutic good?
Therapeutic good is broadly defined as a good which
is represented in any way to be, or is likely to be
taken to be, for therapeutic use (unless specifically
excluded or included under Section 7 of the
Therapeutic Goods Act 1989).
Any product for which therapeutic claims are made
must be either listed or registered in the Australian
Register of Therapeutic Goods.
Jan 25, 2013 40
41. Objective of the Therapeutic
Goods Act 1989:
To provide a national framework for the
regulation of therapeutic goods in Australia
To ensure the quality, safety and efficacy of
medicines
To ensure the quality, safety and performance of
medical devices.
Jan 25, 2013 41
42. Role of the TGA
Pre-market evaluation and approval of registered
products intended for supply in Australia;
Development, maintenance and monitoring of the
systems for listing of medicines;
Licensing of manufacturers in accordance with
international standards of Good Manufacturing
Practice;
Post-market monitoring through sampling, adverse
event reporting, surveillance activities, and response to
public inquiries;
Assessment of medicines for export.
Jan 25, 2013 42
43. Australian Register of
Therapeutic Goods (ARTG)
The ARTG is established under Part 3 of the Act.
Includes a computer database of information about
therapeutic goods for human use which are approved
for supply in, or export from, Australia.
Jan 25, 2013 43
44. Assessment criteria:
Whether a product is listed or registered in the ARTG
depends largely on three things:
Ingredients;
Dosage form of the product; and,
Promotional or Therapeutic claims made for the
product.
Jan 25, 2013 44
