(1995; 156 pages)
WHO Member States adopted the WHO Certification Scheme in 1975 as an instrument to assure the quality of pharmaceutical products moving in international commerce. In spite of its existence for the last 20 years, its use has not been encouraging. Drug regulatory authorities of importing countries lacked appropriate information on the mode of operation of the Scheme and its advantages and limitations when compared to other certificates.
Even though the Scheme has certain limitations and there is the problem of relying on the good faith of exporting countries, it will allow importing countries to receive formal assurance from the regulatory authorities of the exporting countries about the registration status and the quality of the pharmaceutical product they import. Importing countries, therefore, have to make maximum use of the Scheme as recommended by WHO and endeavour to establish their own effectively operational quality assurance system, including drug registration, inspection and quality control laboratory.
Because the Scheme is a non obligatory agreement left open to participation by Member States on a voluntary basis, some exporting countries are not yet party to the Scheme. Others which are committed to the implementation of the Scheme have failed to meet its requirements by not issuing a Certificate of a Pharmaceutical Product for products they export and by not subjecting export products to control measures.
While revision of the Scheme from time to time is essential, it may not serve as a means to promote its implementation. There is, therefore, a need for more concerted international public pressure and better structured informational programmes to increase the commitment of Member States and to promote better implementation of the Scheme. To achieve this it is recommended that:
• ensure that they have an effectively operational drug regulatory system based on legislation, regulations, established procedures and guidelines, and make the WHO Certification Scheme a requirement in drug registration and procurement;
• familiarize registration and procurement personnel with the WHO Certification Scheme through orientation and training programmes;
• maintain a good level of contact with their counterparts in exporting countries so that inadequacies in the quality of drugs can be recognized and tackled by all parties.
• standardize the text of their certificates in accordance with the WHO Certification Scheme and issue a Certificate of a Pharmaceutical Product when requested by importing countries;
• subject pharmaceutical products for export to the same standards of control applied to locally consumed products;
• educate their manufacturers in the purpose and operation of the WHO Certification Scheme and ensure that batch certificates issued by manufacturers make reference to the relevant Certificate of a Pharmaceutical Product issued by the regulatory authority;
• maintain contact with the appropriate regulatory authorities in importing countries to explain and confirm the details of the WHO Certification Scheme.
The World Health Organization
• assist developing countries in their efforts to develop their own drug quality assurance systems;
• initiate informational and promotional programmes for Member States to promote global implementation of the Scheme. The programme should include regional workshops and seminars that involve representatives from regulatory authorities of both importing and exporting countries;
• initiate selected studies on pharmaceutical product flows in the international market as a background for proposals on the use of the Scheme in situations where products are re-exported;
• assess the operation of the Scheme from time to time to evaluate to what extent countries are using it.