(1998; 88 pages)
7.4 WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Countries that do not have professional staff or laboratories to evaluate and handle extensive documentation for registration, may wish to take into account regulatory decisions made in other countries. The WHO certification scheme on the quality of pharmaceutical products moving in international commerce could be applied.
The aim of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce is to assure the quality of imported drugs, especially in small countries that have no drug registration system or no facilities for the systematic evaluation of the quality, efficacy and safety of pharmaceutical products.
A certificate is issued by drug regulatory authorities in exporting countries on request from drug regulatory authorities in importing countries. The certificate issued under the scheme confirms that:
(1) the pharmaceutical product mentioned in the certificate has been: evaluated for quality, safety and efficacy; registered in the country of origin; and approved for sale in that country. An explanation is required if any of these three criteria are not met;
(2) the pharmaceutical product has been manufactured according to Good Manufacturing Practices and that the manufacturing plant in the country of origin has been regularly inspected by the drug regulatory authorities to confirm compliance with GMP;
(3) the labelling and any other written information accompanying the product has been approved by the drug regulatory authority in the country of origin.
A similar system could be used for herbal medicines available for the international market.