The Committee adopted revised guidelines for implementing the expanded Certification Scheme (Annex 10). The proposed guidelines and associated forms published as Annex 3 of the Committee's thirty-second report (5) had been refined following field trials in a number of WHO Member States and discussion during the sixth and seventh biennial International Conferences of Drug Regulatory Authorities. The importance of the Scheme had been endorsed by the Forty-fifth World Health Assembly in resolution WHA45.29. In its revised form, the Scheme was intended to provide more rigorous control through a more effective exchange of authenticated information. The Committee emphasized that the extent to which the Scheme would meet its objectives would depend on the integrity with which it was operated by WHO Member States. It relied, inter alia, on exporting Member States fully meeting the criteria for eligibility, and on importing Member States basing all procurement activities on the Scheme. In the case of products manufactured exclusively for export, the certifying authority had to be satisfied that the quality standards were the same as those applied to products manufactured for sale in the exporting country.
The Committee considered ways in which WHO, in discussion with drug regulatory authorities, might take further steps to strengthen and promote the Scheme. It was recognized that there was a need for more advice and training on the implementation of the Scheme by importing Member States.
A proper appreciation of the value of the Scheme in drug importation could be fostered most effectively by those in close contact with importing authorities. The active role of WHO in implementing the Scheme was acknowledged, and it was suggested that the results of a recent study of its use (12) should be used to target future WHO activity in promoting and supporting the Scheme. As a basis for discussion, the Committee suggested that all those using the Scheme should be encouraged to notify WHO of any problems. Complaints could then be investigated and information collated with a view to proposing possible sanctions, such as the notification of serious abuses of the Scheme to the World Health Assembly.
The Committee recalled that the certification of active pharmaceutical substances was covered by the expanded and revised version of the Certification Scheme as adopted by the Forty-first World Health Assembly in 1988 in resolution WHA41.18. It was informed that the proposals referred to in its thirty-third report would be developed as soon as the guidelines for finished products were finally adopted by the World Health Assembly for implementation.