Moderators: Dr M. Teeling, Ireland, and Dr K. Alawadi Fahimah, United Arab Emirates

The speakers in this session, Mr A. Azam, Fiji, Dr E. Briceno, Venezuela and Professor T. Paal, Hungary, addressed the issues of their certification needs and the advantages and limitations of the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce.

Highly sophisticated drug regulatory authorities devote important resources to assessing the quality, safety and efficacy of drugs before marketing, and to surveying performance in routine use. When such resources are not available, countries often rely on the decisions of other, more highly-developed authorities to ensure safety and efficacy, and focus their assessment on quality.

The WHO Certification Scheme covers any medicine intended for human use or for use in food-producing animals, that is subject to control by legislation in the exporting and in the importing countries. The objective of the Scheme is to provide a simple administrative mechanism whereby importing countries can:

• obtain assurance that a given product has been authorized for placement on the market in the exporting country, and, if applicable, obtain information on the reasons for not being authorized for placement on the market in the country of export;

• obtain assurance that the manufacturing plant in which the product is manufactured is subject to inspections at suitable intervals, and that it conforms to requirements for good practices in the manufacture and quality control of drugs, as recommended by the World Health Organization;

• obtain copies of all information and labelling supplied with the product, as provided on packaging materials and package inserts, and whether directed to the prescriber or the patient, that have been approved by the competent authority in the exporting country, together with the date(s) on which such approval was accorded; and

• exchange information on the implementation of inspection and controls exercised by the authorities in the exporting country. In the case of serious quality defects in the importing or exporting countries, such information and requests for inquiries may also be exchanged.

The Guidelines for implementation of the WHO Certification Scheme were adopted by the World Health Assembly in resolution WHA50.3 in May 1997. Implementation of the Scheme is based on a mechanism of self-assessment by countries intending to use it. Each country assumes responsibility for determining whether it satisfies the required prerequisites through a process of self-evaluation. The Scheme contains no provision, under any circumstance, for external inspection or assessment, either of a competent national authority or of a manufacturing facility.

Proposed improvements to the WHO Certification Scheme

The presentations were followed by a lively question-and-answer session. This discussion led to the conclusion that most of the current limitations of the Scheme are the natural limitations of any system based on certification.

WHO can contribute to the alleviation of the effects of these limitations by disseminating information and raising awareness in order to prevent unrealistic expectations, and by helping countries to strengthen their national authorities with particular emphasis on the development of human resources. Finally, the discussion permitted identification of some possible improvements to the WHO Certification Scheme. These can be outlined as follows.

Certificates for products without marketing authorization in exporting countries should be accompanied by a formal declaration signed by the responsible GMP person at the manufacturing site. Such a declaration should be submitted to the regulatory authority of the exporting country that will take note and assume responsibility for following up on complaints from the importing country’s authorities as to quality defects of the product or inaccuracy of the contents of the declaration.

To reduce the paperwork related to issuance and verification of validity of certificates, WHO should explore the feasibility of establishing electronic certificates. This could be achieved if issuing authorities were to post and regularly update on their Website all the information normally contained in certificates. Importing country authorities would access such Websites directly, to check the required information without requiring applicants to submit certificates on paper.

Such electronic certificates should be complemented by an electronic correspondence system which would permit automatic alerts to be sent to all participating authorities whenever a change is made on the posted information.