1 / 24

Presented by Rutendo Kuwana

Evaluation of quality and interchangeability of medicinal products Training workshop for evaluators from National Medicines Regulatory Authorities in East Africa Community 10-14 September 2007, Dar Es Salaam, Tanzania. Presented by Rutendo Kuwana.

jessie
Download Presentation

Presented by Rutendo Kuwana

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Evaluation of quality and interchangeability of medicinal productsTraining workshop for evaluators from National Medicines Regulatory Authorities in East Africa Community10-14 September 2007, Dar Es Salaam, Tanzania Presented by Rutendo Kuwana Principles of regulation of medicinal products The life cycle

  2. MEDICINE APPROVAL PROCESS FLOW Application Review Additional Data Approval Variations/Amendments PMS Renewal

  3. Receipt of application Application Administrative information Declarations from applicant Complete dossier Date of application Other foreign registrations Application Review Approval Variations/Amendments PMS Renewal

  4. Evaluation of application Review – Standard Report Manufacturing site – address, GMP status, full contact details API Manufacturing site API ROS/Specifications FPP Formulation, Specifications, methods of analysis Shelf life Safety and efficacy data Product info + label Application Review Approval Variations/Amendments PMS Renewal

  5. Approval of Application Approval Certification Database Conditions of authorisation Application Review Approval Variations/Amendments PMS Renewal

  6. Variation of approved information Variations/Amendments Manufacturing site API Manufacturing site API ROS/Specifications FPP Formulation, Specifications, methods of analysis Shelf life Safety and efficacy data Product info + label Application Review Approval Variations/Amendments PMS Renewal

  7. Market Surveillance Post Market Surveillance ADR Product Defects Inspections Laboratory analysis Recalls/withdrawals Application Review Approval Variations/Amendments PMS Renewal

  8. Re-evaluation/Retention Renewal Regular (e.g. every 3 years) Payment of fees Update of information, specifications, methods of analysis Confirmation of safety, efficacy Public interest Application Review Approval Variations/Amendments PMS Renewal

  9. Drug Information and Control of Promotion

  10. Product information and control of promotion Objectives • To understand the role of product information • To understand the minimum content of product information • Appreciate the need for the control of product promotion • Understand the different methods available for the control of promotion

  11. The quality of a drug is not only its identity, purity, strength, safety, efficacy. It is also: • Compliance with regulation • product information • Labelling • patient insert,etc.

  12. A drug is a chemical substance + information The quality of the information accompanying a drug is as important as the quality of the active substance Product information • Label • leaflets/inserts

  13. Product information • Summary of product characteristics submitted as part of the marketing authorization application • Agreed statement between the competent drug regulatory authority and the marketing authorization holder on the approved conditions of use of a product • Content and status is usually defined in law and should be publicly available • Dictates how the product may be promoted to health professionals and the public • For drug to be exported, a copy of the approved product information must accompany the certificate of marketing authorization (WHO-Certification Scheme)

  14. Product information content: (WHO Ethical criteria) • International Non-proprietary Name(INN) of each active substance • Pharmacological data - brief description of pharmacological effects and mechanism of action • Clinical information: - Indications - Dosage regimen and relevant pharmacokinetic data: • average and range for adults and children • dosage interval • average duration of treatment • special situations,e.g., renal failure, etc that require either increased or reduced dosage

  15. Product information content: (WHO Ethical criteria) • Contra-indications • Precautions and warnings (reference to pregnancy, lactation, etc. adverse effects • Drug interactions including drug used for self-medication • Over dosage: • brief clinical description of symptoms • non-drug treatment and supportive therapy • specific antidotes

  16. Product information content: (WHO Ethical criteria) Pharmaceutical information • dosage form • strength of dosage form • excipients • storage conditions and shelf-life • pack sizes • description of the product and package • legal category • name and address of manufacturer(s) and importer(s)

  17. Labelling:information on the immediate or outer packaging/container • usually defined in drug laws • The content has to be consistent with the product information • Serves as a source of information for the distributor/dispenser, prescriber, and consumers

  18. Labelling:content General: primary and secondary containers • The name of the product • Active ingredient (s)( INN) and amount present • Net contents-number of dosage units, weight, volume • Batch number • Expiry date - uncoded form • Storage conditions or handling precautions • Directions for use • Warnings and precautions • Name and address of manufacturer/company/suppliers

  19. Labelling content: WHO manual on assessment Ampoules: • Name of active ingredient(s) and amount /dosage unit • Dosage form/route of administration • Net contents/container • Batch number • Expiry date • Name and address of the manufacturer/supplier

  20. Promotion is a persuasive communication that seeks to influence the attitudes, beliefs and behaviour of people Unaware awareness Interest Trial Use

  21. Promotional methods • Direct • TV advertising, radio, print media (journals, newspapers, magazines), Internet, direct mailings, pamphlets • Personal selling - sales representatives, house to house peddlers • Indirect • Disease awareness campaigns • Sponsorship of information materials-helplines • Links with patient groups • Sales promotion - gifts and samples • Public relations - sponsored symposia, ADR studies

  22. Control of promotion • Government DRA control - pre-approval - surveillance • monitoring very difficult • requires resources • Industry self-regulation - UK- ABPI, Australia-APMA, IFPMA • Needs strong association • Enforcement difficult - no sanctions • Enforced self-regulation - self regulation with sanctions • Tripartite regulation- industry, DRA, public interest groups

  23. Control of promotion • Promotion should be consistent with national health policies and comply with drug regulations • Should comply with the particulars listed in the product information • Should contain reliable claims, without misleading or unverifiable statements • should contain no omissions which lead to health risks • Should not be designed so as to disguise its real nature, for example, as educational or scientific activities • should encourage rational use of the medicinal product

  24. Patient information • Should be accurate & comprehensive • Improve health and enhance outcomes of medical treatment • Empower consumers to make informed decisions • Improve communication between the patient and the health care provider • Should be written in a simple, clear and easily readable language Principles

More Related