Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999
(1999; 53 pages) [French] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAcronyms and abbreviations
View the documentExecutive summary
Open this folder and view contents1. Drug regulation: an early concern
View the document2. Rationale for regulating drugs
View the document3. Where are we today?
Close this folder4. How can drug regulation be made effective?
View the document4.1 Assess drug regulation performance
View the document4.2 Identify and develop priority functions
View the document4.3 Provide a clear mission and purpose
View the document4.4 Create a supportive environment
View the document4.5 Formulate adequate drug legislation
View the document4.6 Create appropriate organizational structure
View the document4.7 Allocate adequate human and financial resources
View the document4.8 Minimize corruption and conflict of interest
View the document4.9 Apply most appropriate strategy
View the document5. The way forward
View the documentAnnex 1. Status of drug regulation and drug quality assurance in WHO African Region and selected countries
View the documentAnnex 2. A model framework for assessing drug regulation
View the documentAnnex 3. Possible approaches to developing drug regulation a
View the documentAnnex 4. Examples of mission statements concerning drug regulation
View the documentAnnex 5. Fees collected for drug registration
View the documentReferences
 

4.3 Provide a clear mission and purpose

A clear written mission, based on priorities and functions, should be provided for drug regulation, indicating what it intends to achieve. Clear definition of the mission will facilitate assessment of the degree to which drug regulation has met its central goals, and of whether the perceived objective has changed between inception and implementation. Identifying the beneficiaries and stakeholders of drug regulation is also important since this helps ensure that an appropriate implementation strategy is designed.

Although the core mission of drug regulation for all countries is to promote public health by ensuring the quality, safety and efficacy of drugs, and appropriate and accurate product information, the mission may also include:

• providing unbiased information and promoting rational use of drugs;
• ensuring timely availability of drugs (through, for example, prompt registration of new products);
• ensuring geographical access to drugs (through decisions on location of retail outlets);
• encouraging domestic production of drug products.

Some examples of mission statements concerning drug regulation are given in Annex 4.

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Last updated: January 19, 2012