Post on 17-May-2015
transcript
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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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.
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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
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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
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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
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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.
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MHRAMHRA
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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.
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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
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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.
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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.
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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:
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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.
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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.
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What UK MCA regulate?
It regulates a wide range of materials;
Medicines
Medical devices
Blood
Therapeutic products/services that are derived from
tissue engineering.
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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)
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TGA (Therapeutic Goods Administration)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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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