Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Open this folder and view contents1. General considerations
Close this folder2. Administrative aspects of the licensing process
View the document2.1 Provisional registration of existing medicinal products
View the document2.2 Screening of provisionally registered products
View the document2.3 New product licences
View the document2.4 Renewal and variation of licences
Open this folder and view contents3. Technical aspects of the licensing process
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
2.2 Screening of provisionally registered products

A rapid screening of notified products should be undertaken at the earliest opportunity with a view to securing the withdrawal of any products which, simply on the basis of a review of their ingredients and indications, are judged not to meet admissible standards of safety. This may be achieved by the withdrawal of permission to trade in specific notified products or the issuance of regulations imposing specified restrictions on precisely defined groups of products. After this preliminary review, a set of longer-term priorities needs to be set for the definitive assessment of provisionally registered products. Consideration needs to be given to the resources required, both in manpower and information, if the review is to be adapted to a proposed time-schedule. Standards must be maintained and calls to accelerate the speed of implementation must be recognized as having resource implications.

In planning priorities, consideration must be given to:

(a) the number of provisionally registered products to be processed;

(b) the number of staff and/or consultants to be allocated to the task;

(c) the amount of relevant information available from other national authorities;

(d) the extent to which products can be reviewed in groups rather than individually;

(e) the extent to which a laissez-faire disposition can be adopted towards such products as herbal remedies and tonics that are without potent pharmacological activity and carry imprecise claims, but which satisfy an acknowledged public demand.

Considerations of safety require that particular attention be accorded to:

(a) products that either have been withdrawn or are the subject of restrictive regulatory action in other countries as notified in the United Nations Consolidated List of Products Whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, and in WHO’s Pharmaceuticals newsletter to national drug regulatory authorities;

(b) products representing examples of irrational poly-pharmacy; and

(c) products for which exaggerated or spurious promotional claims are made in the labelling.

Subsequently, the review needs to be extended in a phased manner, giving priority to drugs that are widely used, listed in nationally recognized formularies, or of a particularly important therapeutic class. An adequate documentation and information retrieval system is vital for this purpose. Some traditional products and particularly herbal preparations, because of their complexity, do not lend themselves to licensing on a product-specific basis. Control is then more readily applied through consideration of individual ingredients. Several regulatory authorities have devised administrative approaches to their licensing which are based on a three-category system of classification:

(a) all herbal ingredients, save for those items classified under (b) below, which may be dispensed for a specific, named patient by practitioners of herbal medicine who do not possess a formal medical qualification;

(b) ingredients such as digitalis leaf and atropine which, because of their pharmacological potency or their toxicity, need to be subjected to prescription control; and

(c) ingredients which, as a result of widespread, long-established and apparently innocuous traditional usage, are included, often within defined permissible limits, in labelled products for which limited claims are made and which are sold directly to the public from retail outlets other than pharmacies.

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