Effective drug regulation : a multicountry study / by Sauwakon Ratanawijitrasin, Eshetu Wondemagegnehu.

Format:

Book

Government document

Author/Creator:

Ratanawijitrasin, Sauwakon.

Contributor:

Wondemagegnehu, Eshetu.

Language:

English

Subjects (All):

Drugs--Law and legislation.

Drugs.

Pharmaceutical policy.

Physical Description:

x, 149 p. : ill.

Edition:

1st ed.

Place of Publication:

[Geneva] : World Health Organization, 2002.

Language Note:

English

Summary:

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.

Contents:

Intro

CONTENTS

1. DRUG REGULATION: OBJECTIVES AND ISSUES

1.1 Drugs as an instrument of public health

1.2 Controlling private behaviour for public purposes

1.3 Objectives and organization of this report

2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION

2.1 Project rational and development

2.2 Study objectives

2.3 Method of study

2.4 Drug regulation from a comparative perspective

3. PROFILE OF THE COUNTRIES

3.1 General background

3.2 Political environment

3.3 Pharmaceutical sector environment

4. REGULATORY FRAMEWORK

4.1 Missions and goals of drug regulation

4.2 Domains of control

4.3 Other non-regulatory pharmaceutical functions

4.4 National drug policy

4.5 Historical development of drug regulation

5. REGULATORY CAPACITY

5.1 Legal basis, organizational structure and authority

5.2 Human resources

5.3 Financing drug regulation

5.4 Planning, monitoring and evaluating implementation

5.5 Problems encountered and strengths identified

5.6 Political influence and accountability

6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE

6.1 Power and process

6.2 Human resources

6.3 Paying for licensing

6.4 Performance

7. INSPECTION AND SURVEILLANCE

7.1 Power and process: comparing structures and processes

7.2 Human resources

7.3 Paying for inspection

7.4 Planning, process and performance

8. PRODUCT ASSESSMENT AND REGISTRATION

8.1 Power and process

8.2 Human resources

8.3 Paying for registration

8.4 Performance

8.5 Adverse drug reaction monitoring

8.6 Clinical trials

9. CONTROL OF DRUG PROMOTION AND ADVERTISING

9.1 Power and process: comparing structures and processes

9.2 Performance

10. DRUG QUALITY CONTROL LABORATORY

10.1 Power and process

10.2 Human resources

10.3 Paying for quality control.

10.4 Performance

11. ASSESSING REGULATORY PERFORMANCE

11.1 Assessing government functions: an essential part of policy-making

11.2 Monitoring and evaluation system

11.3 Monitoring and evaluating the effectiveness of drug regulation

11.4 Monitoring and evaluating the efficiency of drug regulation

11.5 Monitoring and evaluating the accountability and transparency of drug regulation

11.6 Availability of information for assessment

12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION

12.1 Conclusions related to regulatory structures

12.2 Conclusions related to regulatory processes

12.3 Recommendations for effective drug regulation.

Notes:

"This report is a synthesis of the results of the multicountry studies carried out by the WHO Essential Drugs and Medicines Policy Unit (EDM)."--P. ix.

Includes bibliographical references.

ISBN:

1-280-06038-7

92-4-068029-2

9786610060382

OCLC:

935263257