Get documents about "Evaluation of quality and interchangeability of medicinal products
Document Sample
Principles of regulation of medicinal
products
The life cycle
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
MEDICINE APPROVAL PROCESS FLOW
Application
Review Additional Data
Approval
Variations/Amendments
PMS
Renewal
2| Principles of medicine regulation
Receipt of application
Application Application
Administrative information
Review
Declarations from applicant
Approval Complete dossier
Date of application
Variations/Amendments
Other foreign registrations
PMS
Renewal
3| Principles of medicine regulation
Evaluation of application
Application Review – Standard Report
Manufacturing site – address,
Review GMP status, full contact details
API Manufacturing site
Approval
API ROS/Specifications
FPP Formulation, Specifications,
Variations/Amendments methods of analysis
Shelf life
PMS
Safety and efficacy data
Product info + label
Renewal
4| Principles of medicine regulation
Approval of Application
Application
Approval
Certification
Review
Database
Approval
Conditions of authorisation
Variations/Amendments
PMS
Renewal
5| Principles of medicine regulation
Variation of approved information
Application Variations/Amendments
Manufacturing site
Review
API Manufacturing site
Approval API ROS/Specifications
FPP Formulation, Specifications,
Variations/Amendments methods of analysis
Shelf life
PMS
Safety and efficacy data
Product info + label
Renewal
6| Principles of medicine regulation
Market Surveillance
Application Post Market Surveillance
ADR
Review
Product Defects
Approval
Inspections
Variations/Amendments Laboratory analysis
Recalls/withdrawals
PMS
Renewal
7| Principles of medicine regulation
Re-evaluation/Retention
Application Renewal
Regular (e.g. every 3 years)
Review
Payment of fees
Approval
Update of information,
specifications, methods of
Variations/Amendments analysis
Confirmation of safety,
PMS efficacy
Public interest
Renewal
8| Principles of medicine regulation
Drug Information and Control of
Promotion
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
10 | Principles of medicine regulation
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.
11 | Principles of medicine regulation
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
12 | Principles of medicine regulation
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)
13 | Principles of medicine regulation
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
14 | Principles of medicine regulation
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
15 | Principles of medicine regulation
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)
16 | Principles of medicine regulation
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
17 | Principles of medicine regulation
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
18 | Principles of medicine regulation
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
19 | Principles of medicine regulation
Promotion is a persuasive communication that seeks to influence the
attitudes, beliefs and behaviour of people
Unaware awareness Interest
Trial
Use
20 | Principles of medicine regulation
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
21 | Principles of medicine regulation
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
22 | Principles of medicine regulation
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
23 | Principles of medicine regulation
Patient information
Principles
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
24 | Principles of medicine regulation
