Quality of antimalarial medicines
Observing stringent quality standards for antimalarial medicines is crucial in order to ensure that safe and effective products are consistently made available for widespread use. Poor quality medicines and drug related adverse effects not only affect the health and lives of patients, they also damage the credibility of health care programmers and waste scarce resources.
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Challenges to maintaining quality
Stringent quality standards are particularly important for artemisinin-based antimalarial medicines, since the extraction process of the active pharmaceutical ingredient from plant origin is complex, and chemical instabilities may arise in the manufacturing process of the finished pharmaceutical products. The use of ineffective or unsafe substandard products in the treatment of malaria may not only be harmful, it might also favour the emergence and spread of resistant parasites and thus limit the effecive life of this very important class of medicines.
Assuring quality of antimalarial medicines
To ensure the quality of Finished Pharmaceutical Products, internationally agreed standards accept both the approval of medicines by Stringent Regulatory Authorities and the recommendation of products by the WHO Prequalification Programme; additionally, product samples need to be evaluated by pre-shipment or post-shipment quality control mechanisms.
Regulatory Authorities participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are considered to be stringent. (www.ich.org)
The WHO Prequalification Programme assesses products following a standardized procedure that includes the review of product dossiers and the inspection of the manufacturing site in order to ensure that products comply with recommended quality standards. A list of WHO-prequalified antimalarial medicines can be obtained from the webpage of the WHO Prequalification Programme.
Post-Marketing Surveillance and Pharmacovigilance of antimalarials
New medicines are registered and enter the market with limited safety evaluation during clinical trials; rare unexpected side effects can only be detected during large-scale use. Safety data is particularly lacking for infants and pregnant women, as these populations are frequently not included in pre-registration clinical trials. WHO promotes good pharmacovigilance to detect, understand and prevent adverse effects related to medicines, in the shortest possible time after their introduction in the market.