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Agencies dhwani Agencies dhwani Presentation Transcript

  • Presented by : PARTH M.Pharm (sem:2) Department of Quality Assurance K.B.Raval College of Pharmacy Enroll. no. :11 Guided By: Pranit PatelJan 25, 2013 1
  • 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 OrganizationJan 25, 2013 2
  • US FDAJan 25, 2013 3
  •  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 ofo Foodso Tobacco productso Dietary supplementso Prescription and non-prescription medicationso Vaccineso Biopharmaceuticalso Blood transfusionso medical deviceso Electro magnetic radiation emitting deviceso veterinary productso cosmeticsJan 25, 2013 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.Jan 25, 2013 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 animalsJan 25, 2013 6
  • 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 problemJan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 13
  • c) Over-the-counter drugs• Over-the-counter (OTC) drugs are drugs and combinations that do not require a doctors 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
  • 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
  • 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
  • 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 drugsJan 25, 2013 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 AgricultureJan 25, 2013 18
  • 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 act Jan 25, 2013 192004 Food allergy labeling and consumer protection act
  • FDA Components:Sr. Componen Full Form Regulatesno tA CBER Center For Biologics Biological Products. Evaluation And ResearchB 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. ResearchD 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 SafeF NCTR National Center For Human ToxicologyJan 25, 2013 Toxicological Research 20
  • 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
  •  Biologics product and manufacturing establishment licensing safety of the nations 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 standardsJan 25, 2013 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 Jan 25, 2013 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 devicesJan 25, 2013 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.Jan 25, 2013 25
  • MHRA UK MCAJan 25, 2013 26
  • 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
  • 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  ConsistencyJan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 30
  • UK MCAs StructureThe MHRAs 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 Agencys Chief Executive Officer.2)The Chief Executive: Responsible for service delivery and resources.3)The Executive Board: Consisting of the Agencys directors, takes overall responsibility for day-to-day management,4)The Risk and Audit Committee:Jan 25, 2013 31
  • UK MCAs 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
  • UK MCAs 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 devicesJan 25, 2013 33
  • UK MCAs 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
  • 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
  • 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
  • TGA (Therapeutic Goods Administration)Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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.Jan 25, 2013 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 medicinesJan 25, 2013 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.govJan 25, 2013 46
  • Jan 25, 2013 47