Presented by :PARTH

M.Pharm (sem:2)Department of Quality Assurance

K.B.Raval College of PharmacyEnroll. no. :11

Guided By:Pranit Patel

Apr 12, 2023 1

STANDARD INSTITUTE:STANDARD INSTITUTE:

BSS: British Standard Specification

ISO: International Organization for Standardization

ASTM: American Society for Testing and Materials

ISI: Indian Standard Institution

REGULATORY AUTHORITY: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 OrganizationApr 12, 2023 2

US FDAUS FDA

Apr 12, 2023 3

USFDAUSFDA 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 Foodso Tobacco productso Dietary supplementso Prescription and non-prescription medicationso Vaccineso Biopharmaceuticalso Blood transfusions o medical deviceso Electro magnetic radiation emitting devices o veterinary products o cosmeticsApr 12, 2023 4

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.

Apr 12, 2023 5

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

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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

Apr 12, 2023 7

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.Apr 12, 2023 8

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.

Apr 12, 2023 9

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.

Apr 12, 2023 10

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.

Apr 12, 2023 11

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.

Apr 12, 2023 12

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.

Apr 12, 2023 13

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.

Apr 12, 2023 14

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.

Apr 12, 2023 15

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.

Apr 12, 2023 16

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

Apr 12, 2023 17

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

Apr 12, 2023 18

Apr 12, 2023 19

Year Advancement in FDA1820 U.S Pharmacopoeia1897 Drug importation Act1883 Bureau of Chemistry’s Food adulteration Studies1902 The Biologics Control Act1906 The original Food and Drugs Act is passed1933 Complete revision of the obsolete 1906 Food and Drugs Act.1907 Certified Color Regulations1937 Elixir of Sulfanilamide, containing the poisonous solvent diethylene

glycol, kills 107 persons,1939 First Food Standards1949 Guidence to industry On procedure for the appraisal of toxicity of

chemical in food.1954 Radiological examination of food1966 Child protection act1971 National centre for Toxicological research1976 Medical device amendments1982 Temper resistant packaging regulations1994 Dietary supplement health and education act2004 Food allergy labeling and consumer protection act

Apr 12, 2023 20

Sr.no

Component

Full Form Regulates

A CBER Center For Biologics Evaluation And Research

Biological Products.

B CDRH Center For Devices And Radiologic Health

Safety and Effectiveness of New medical Devices Before they are Marketed.

C CDER Center For Drug Evaluation And Research

Assuring Prescription and OTC Drugs are Safe and Effective.

D CSFAN Center For Food Safety And Applied Nutrition

Food Supply is Safe, Sanitary, Wholesome and Honestly labeled.

E CVM Center For Vaterinary Medicines

Assure that Animal Food Products are Safe

F NCTR National Center For Toxicological Research

Human Toxicology

FDA Components:

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.

Apr 12, 2023 21

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

Apr 12, 2023 22

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

Apr 12, 2023 23

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

Apr 12, 2023 24

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.

Apr 12, 2023 25

MHRAMHRA

Apr 12, 2023 26

UK MCAUK MCA

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.

Apr 12, 2023 27

Mission To enhance and protect the health of the public by

ensuring that medicines and medical devices work, and are acceptably safe. 

ValuesTo fulfill this mission they will act with:

Integrity Openness Responsiveness Timeliness Professionalism Impartiality Consistency

Apr 12, 2023 28

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.

Apr 12, 2023 29

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.

Apr 12, 2023 30

UK MCA's StructureThe 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:

Apr 12, 2023 31

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.

Apr 12, 2023 32

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

devicesApr 12, 2023 33

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.

Apr 12, 2023 34

What UK MCA regulate?

It regulates a wide range of materials;

Medicines

Medical devices

Blood

Therapeutic products/services that are derived from

tissue engineering.

Apr 12, 2023 35

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)

Apr 12, 2023 36

TGA (Therapeutic Goods Administration)

Apr 12, 2023 37

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.

Apr 12, 2023 38

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.

Apr 12, 2023 39

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.

Apr 12, 2023 40

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.

Apr 12, 2023 41

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.

Apr 12, 2023 42

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.

Apr 12, 2023 43

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.

Apr 12, 2023 44

Listed medicines Regulated by TGA

Registered medicines

Non-prescription (low risk) registered

Prescription (high risk) registered

Complementary medicines

Regulating medicines

Regulating medical devices

OTC medicines

Apr 12, 2023 45

References

Dr.B.S.Kuchekar, Mr.Sachin C.Itkar ‘Forensic Pharmacy’, Fifth Edition , page no 17.8-17.15

www.mhra.gov.uk www.tga.gov.au www.usfda.gov

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