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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.
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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
MEDICINE APPROVAL PROCESS FLOW Application Review Additional Data Approval Variations/Amendments PMS Renewal
Receipt of application Application Administrative information Declarations from applicant Complete dossier Date of application Other foreign registrations Application Review Approval Variations/Amendments PMS Renewal
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
Approval of Application Approval Certification Database Conditions of authorisation Application Review Approval Variations/Amendments PMS Renewal
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
Market Surveillance Post Market Surveillance ADR Product Defects Inspections Laboratory analysis Recalls/withdrawals Application Review Approval Variations/Amendments PMS Renewal
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
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
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.
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
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)
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
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
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)
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
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
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
Promotion is a persuasive communication that seeks to influence the attitudes, beliefs and behaviour of people Unaware awareness Interest Trial Use
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
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
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
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