The main tasks of a DRA are to ensure the quality, safety and efficacy of drugs (including traditional and herbal medicines), and the appropriateness of product information. These four aspects can be translated into a set of core elements of drug regulation (see Box 7).
Box 7
Core elements of drug regulation |
Quality: |
Review of quality as part of product registration
Formulation of norms and standards
Licensing of facilities and personnel
Inspection of facilities and products
Drug quality control |
Safety: |
Review of safety as part of product registration
Adverse drug reaction monitoring
Issue of warnings, recall of products |
Efficacy: |
Review of efficacy as part of product registration
Authorization of clinical trials |
Information: |
Review and approval of product data sheets and labels
Regulation of advertising and drug promotion |
The various core elements are discussed in sections 8.5-8.9, with reference to relevant WHO publications and other materials that provide the necessary technical details.
Building an effective and efficient drug regulatory authority is a long and arduous task that may take years to accomplish, with considerable personnel and financial investment. A stepwise approach is usually recommended. In this respect, WHO’s National drug regulatory legislation: guiding principles for small drug regulatory authorities is relevant for countries with limited resources.45 This document and most other relevant materials have been brought together in a compendium of WHO guidelines and related materials, published in two volumes.46
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