Quality and Data Integrity in BE Trials: The Prequalification Paradigm
Anders Fuglsang,
Consultant and Founder,
Fuglsang Pharma
Through procurement of generic/multisource medicinal products the World Health Organization's prequalification programme provides treatment options for patients suffering from e.g. Malaria, Tuberculosis and HIV/AIDS. To a large extent quality is assured through WHO's own guidelines, some of which are much more specific to actual work processes than guidances issued by other regulatory authorities. As of April 2016 a revision to the WHO guideline for organizations involved in the bioequivalence testing of generic/multisource products has been issued. In this talk some of the significant changes are introduced, and their justification is discussed on basis of recent inspection findings and Notices of Concern. It is in the interest of all stakeholders that WHO be able to procure safe and efficaceous medicines of high quality. Further erosion of the reputation of the testing industry in India can hopefully be prevented, possibly even reversed. For that reason active and relevant involvement from DCGI/CDSCO, Sponsors, CROs, and IECs is desirable.
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