WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Close this folderAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
View the documentIntroduction
View the documentDrafting national legislation: points for consideration
View the documentDefining the scope of the marketing authorization procedure for medicinal products
Close this folderExample of a legislative scheme for regulating medicinal products
View the documentGeneral considerations
View the documentPotential value of the scheme
Open this folder and view contentsModel legislative text and commentary
View the documentReferences
View the documentSelected bibliography
View the documentAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
View the documentAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

General considerations

The structure of the example legislative scheme is based on certain assumptions. Most small developing countries have only a few qualified health professionals and are thus compelled to assign a variety of functions and responsibilities to every available official. This is in contrast to the situation in developed countries, and even in developing countries with adequate human resources for health, where there is always a group of officials - often operating within a hierarchical structure supported by advisers and committees - entrusted with regulatory responsibilities for different health care products or products with health implications such as drugs, food, devices, herbal medicines, cosmetics, pesticides, chemicals, narcotics, etc.

In the regulatory arena, it is customary to work through institutional mechanisms such as boards, committees or commissions consisting of several professionals. In countries without any regulatory system in place, members of a newly created mechanism will normally have to function almost on a day-to-day basis until most of the preliminary work is completed. With only a handful of qualified health professionals available to attend to all the functions in the ministry of health and even in the hospitals, it will be difficult for some small developing countries to ensure that such boards or committees will even have a quorum. Even if such boards or committees are created, it may well be that one or two officials will have to undertake most of the routine work.

This legislative scheme envisages the establishment of a drug regulatory authority or of a medicinal products board. The latter mechanism is particularly appropriate for those countries which are able to assign a sufficient number of personnel to serve on such a board. In this event, provision can be made for the appointment of a secretary to the board.

The scheme applies only to "medicinal products" (hereafter referred to as medicinal products or products). However, there is flexibility to extend the scheme to cover other health-related products, if so desired. It may well be that some countries wish to extend the same (or similar) control regimes to other products such as devices, herbal medicines, food and cosmetics, with a few additional provisions and regulation-making powers.

The drug regulatory authority or the board will be the authority in charge of the day-to-day implementation of the law. The legislative scheme provides for the creation of a small advisory committee to give guidance on general or specific policy and other related issues. The nature and composition of the board and the advisory committee depend essentially on the expertise that is available in the country and that can be mobilized for the purpose. For this reason, the size, composition and other details are not specified in the scheme itself, but left to be addressed in the regulations.

The control system provided for by the legislative scheme is structured around an "inventory" of the medicinal products available in the country. Regulation is not possible unless there is the information on available products (i.e. imported and/or manufactured) shortly after the law has come into operation.

The first step towards regulation of medicinal products is essentially the compilation of the inventory. Manufacturers and importers can be required, by law, to transmit to the drug regulatory authority or the board relevant information concerning the products placed on the market on or before a particular date (appointed date), as may be specified in an official publication such as the gazette. Notification will have the effect of "provisional authorization/registration" for the product. Notified products will be listed in an inventory which will be published or made available for public inspection. After the appointed date, a medicinal product for which information has not been provided and which does not have the status of being provisionally authorized/registered may not be imported or manufactured without the written permission of the drug regulatory authority or the board, thus facilitating control over the medicinal products currently on the market.

Provisionally authorized/registered medicinal products listed in the inventory will be subjected to a rapid screening process, primarily to secure the withdrawal of those products that do not meet standards of quality, safety and efficacy. The definitive assessment of provisionally authorized/registered medicinal products will be planned in accordance with established priorities.

New products (i.e. those not provisionally authorized/registered) may be imported or manufactured only with the prior written permission of the drug regulatory authority or of the board. Products which are the subject of applications after the appointed date for import or manufacture will be subjected to technical assessment before authorization/licence is granted.

While the proposed legislative scheme is primarily concerned with the control of medicinal products that are being imported or manufactured or sought to be imported or manufactured, the scheme provides for control of products for export as well.

Modern information technology, using desk-top computers, will facilitate the recording, updating and retrieval of information and entries (see Appendix 2). In the not too distant future it should be possible to access regulatory information provided by selected regulatory authorities and by relevant international organizations such as WHO.

As regulatory decisions affect the parties involved in manufacture, import, export or distribution, the legislative scheme provides for a right of appeal to the minister or to another administrative authority against any decision of the drug regulatory authority or the board. The minister or such other authority may, upon considering the facts of the case, decide to affirm, modify, or rescind the decision of the drug regulatory authority or the board, or to refer it back to the drug regulatory authority or the board for reconsideration. The right of appeal to the minister or to another administrative authority is an administrative safeguard, as an aggrieved person will always have the right to appeal to a court of law, in accordance with the general laws of the country. As the decision of the minister or of such other authority will be subject to scrutiny, subject to applicable legal principles, the minister or the authority will be expected to exercise an unbiased perspective based on sound policy, scientific knowledge and the particular facts of the case. Courts of law are not normally concerned with technical decisions determined by those with the necessary scientific or technical experience and skills.

Critical to the success of the approach on which this legislative scheme is based is maximum use (through the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce) of regulatory information concerning individual medicinal products available through drug regulatory authorities. Regulatory information disseminated by WHO will also be of value here (see Appendix 2).

Besides regulating medicinal products, the legislative scheme may also regulate - through an authorization/licensing system - those who manufacture, import, export, store, dispense or distribute medicinal products. The scheme provides for regulations to specify who may be eligible for authorizations/licences and the procedures for applying for such authorizations/licences.

The legislative scheme contains only the minimum or basic provisions which a law must contain to provide a sound legislative basis for regulating drugs or medicinal products. In adapting this law to suit individual needs and circumstances additional provisions may have to be included. The provisions of the legislative scheme will be in addition to those already contained in other legislation dealing with health practitioners, such as medical practitioners and pharmacists. (See Appendix 1 for an example of a legislative scheme concerned with the registration of pharmacy personnel.)

Due to constitutional or administrative legal principles, the laws and regulations of some countries do not necessarily apply to the state or public sector, unless there is specific provision to the contrary. Even if they do apply, sometimes they are not as strictly followed as in the private sector or by the general public. This legislative scheme provides for the state or the public sector to be bound to the same extent as the private sector or the general public. There is no scientific basis for exempting medicinal products procured or manufactured by or on behalf of the state or the public sector from regulatory and control regimes.

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