Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Close this folderCurrent topics
View the document“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
View the documentWHO Certification Scheme: input for implementation
View the documentValue of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
View the documentPharmacopoeial specifications for new drug entities
View the documentImproving the impact of drug regulatory authorities on public health
View the documentStrengthening drug regulatory authorities in small Pacific Island nations
View the documentTransparency of data
View the documentKava
View the documentXenotransplantation and xenotourism: time for concerted regulatory action
View the documentRecommendations
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

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.

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