(1999; 168 pages) [Spanish]
Potential value of the scheme
The basis on which the legislative scheme is structured is of particular value to small national drug regulatory authorities, with limited human and other resources, for a number of reasons:
• The scheme requires an inventory of medicinal products on the market to be compiled, and places the burden of providing the necessary information on importers, manufacturers and exporters. After the appointed date, a medicinal product for which the necessary documentation has not been submitted may not be imported, manufactured or exported without the written permission of the drug regulatory authority or the board, thus facilitating supervision of the movement of medicinal products on the market.
• The inventory can be compiled using a small desk-top computer with a software program tailor-made for the purpose.
• After the appointed date, the drug regulatory authority or the board can decide on the type of regulatory action to be taken for any individual medicinal product or group of medicinal products, bearing in mind the country's national drug policy and health care needs, and the nature of the regulations covering the product in other countries that have comprehensive systems in place for the assessment and regulation of medicinal products. The scheme provides for a system of "provisional authorization/registration" for medicinal products for which information was provided on or before the appointed date, and a system of product licensing for medicinal products proposed for import, manufacture or export after the appointed date. Provisionally authorized/registered medicinal products must qualify for product licences/marketing authorizations after evaluation, or may have to be withdrawn from the market if so decided by the drug regulatory authority or the board. The process for such evaluation has to be phased in as small national drug regulatory authorities without trained personnel or adequately equipped laboratories will find it difficult to undertake the assessment and registration of drugs following the same procedures as countries where regulatory systems have evolved over many decades and which are able to rely on qualified personnel for the assessment of medicinal products.
• The scheme is flexible enough to permit provisionally authorized/registered medicinal products to remain on the market until such time as a decision is taken to prohibit or otherwise regulate them, thus preventing any sudden or artificial shortages. This approach is preferred to those which do not permit any medicinal products to be marketed unless authorized, registered or licensed since personnel constraints will not permit the speedy assessment of medicinal products. Under the scheme the market will be gradually regulated through a process of assessment leading to product registration or withdrawal of the provisionally registered status. As described in section 2.2 of the "Guiding principles for small national drug regulatory authorities" (2), entitled "Screening of provisionally registered products", the initial screening process must be rapid to secure the withdrawal of products which, on the basis of a review of their ingredients and indications, are judged not to meet admissible standards of safety, quality and efficacy. This must be followed by the phased-in definitive assessment of all provisionally authorized/registered products according to priority. Applications for products which are to be imported, manufactured or exported for the first time after the appointed date will be assessed at the same time.
• In addition to screening individual medicinal products, or groups of medicinal products, the legislative scheme provides for regulatory action of a general nature. Through regulations or orders provision can be made for compliance with good manufacturing standards; the use of the WHO Certification Scheme on the Quality of Pharmaceuticals Moving in International Commerce: compliance with International Nonproprietary Names (INNs) for pharmaceutical substances, labelling and advertising requirements, etc.