Transcript Principles of regulation of medicinal products with special attention

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
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Principles of medicine regulation
Receipt of application
Application
Application
 Administrative information
Review
Approval
 Declarations from applicant
 Complete dossier
 Date of application
Variations/Amendments
PMS
Renewal
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Principles of medicine regulation
 Other foreign registrations
Evaluation of application
Application
Review
Review – Standard Report
 Manufacturing site – address,
GMP status, full contact details
 API Manufacturing site
Approval
Variations/Amendments
 API ROS/Specifications
 FPP Formulation, Specifications,
methods of analysis
 Shelf life
PMS
Renewal
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Principles of medicine regulation
 Safety and efficacy data
 Product info + label
Approval of Application
Application
Review
Approval
 Certification
 Database
Approval
Variations/Amendments
PMS
Renewal
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Principles of medicine regulation
 Conditions of authorisation
Variation of approved information
Application
Variations/Amendments
 Manufacturing site
Review
 API Manufacturing site
Approval
Variations/Amendments
 API ROS/Specifications
 FPP Formulation, Specifications,
methods of analysis
 Shelf life
PMS
Renewal
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Principles of medicine regulation
 Safety and efficacy data
 Product info + label
Market Surveillance
Application
Review
Post Market Surveillance
 ADR
 Product Defects
Approval
Variations/Amendments
 Inspections
 Laboratory analysis
 Recalls/withdrawals
PMS
Renewal
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Principles of medicine regulation
Re-evaluation/Retention
Application
Review
Renewal
 Regular (e.g. every 3 years)
 Payment of fees
Approval
Variations/Amendments
PMS
 Update of information,
specifications, methods of
analysis
 Confirmation of safety,
efficacy
 Public interest
Renewal
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Principles of medicine regulation
Drug Information and Control of
Promotion
Product information and control of
promotion
Objectives
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
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
Principles of medicine regulation
The quality of a drug is not only its identity, purity,
strength, safety, efficacy. It is also:
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
Compliance with regulation

product information

Labelling

patient insert,etc.
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
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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)
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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
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Principles of medicine regulation
Product information content: (WHO Ethical
criteria)




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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
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)
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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
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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
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Batch number

Expiry date - uncoded form

Storage conditions or handling precautions

Directions for use

Warnings and precautions

Name and address of manufacturer/company/suppliers
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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
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Net contents/container

Batch number

Expiry date

Name and address of the manufacturer/supplier
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Principles of medicine regulation
Promotion is a persuasive communication that seeks to influence the
attitudes, beliefs and behaviour of people
Unaware
awareness
Trial
Use
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Principles of medicine regulation
Interest
Promotional methods
 Direct
– TV advertising, radio, print media (journals, newspapers,
magazines), Internet, direct mailings, pamphlets
– Personal selling - sales representatives, house to house peddlers
 Indirect
–
–
–
–
–
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Disease awareness campaigns
Sponsorship of information materials-helplines
Links with patient groups
Sales promotion - gifts and samples
Public relations - sponsored symposia, ADR studies
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
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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
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Principles of medicine regulation
Patient information
Principles
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
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 of medicine regulation