(2002; 166 pages)
WHO Certification Scheme: input for implementation
Dr Maura Linda Sitanggang, Indonesia
The WHO Certificate of Pharmaceutical Product (CPP) is a document that gives information on the safety and efficacy of a pharmaceutical product. However, for some products, safety labelling and indicated use may differ from one country to another. For example, marketing authorization for sibutramine has been suspended in some countries because of reported cardiovascular side-effects, although it is still under review with inconclusive results in other countries. Meanwhile, industry claims that the drug is safe for pathological obesity as long as it is not used as a slimming pill. Similarly, the awareness of relative risk with the use of synthetic or natural-based hormonal compounds in hormone replacement therapy is different in different countries. It is difficult for the WHO CPP scheme address the differing safety aspects of such cases.
Regarding efficacy, for rofecoxib, there are different indications stated in CPP from different countries, such as osteoarthritis in some countries and osteoarthritis and acute pain in others. As the CPP is an instrument within the WHO Certification Scheme used when a product is under consideration for a product licence in a country, it would be useful if the certification process could provide guidance and clarification on the safety, efficacy, and quality of pharmaceutical products entering different countries.