(1997; 248 pages) [French]
1. General considerations
The national health authorities (national drug regulatory authorities) should ensure that all pharmaceutical products subject to their control are in conformity with acceptable standards of quality, safety and efficacy, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with GMP standards so as to ensure the continued conformity of the products with these requirements until such time as they are delivered to the end user.
These objectives can be accomplished effectively only if a mandatory system of marketing authorization for pharmaceutical products and the licensing of their manufacturers, importing agents and distributors exists and adequate resources are available for implementation. Health authorities in countries with limited resources are less able to perform these tasks. To assure the quality of imported pharmaceutical products and drug substances, they are therefore dependent on authoritative, reliable, and independent information from the drug regulatory authority of the exporting country. This information, including information on the regulatory status of a pharmaceutical product, and the manufacturer’s compliance with GMP (2) in the exporting country, is most effectively obtained through the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce [see pp. 187-209], which provides a channel of communication between the regulatory authorities in the importing and exporting countries (see World Health Assembly resolutions WHA41.18 and WHA45.29).
The essential functions and responsibilities of a drug regulatory authority have been further elaborated by WHO in the guiding principles for small national drug regulatory authorities (3, 4).