WHO has prequalification multisource (generic) guideline

Home/Policies & Legislation | Posted 31/08/2009 post-comment0 Post your comment

On 18 June 2009, WHO published a Prequalification Update, informing that a guideline on submission of documentation for prequalification of multisource (generic) has been completed and that Finished Pharmaceutical Products (FPPs) will be approved by Stringent Regulatory Authorities (SRAs). It states that WHO recognises the scientific evaluation of multisource (generic) products by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy as those recommended by WHO.

Where an applicant and an SRA can agree to share Guideline on Submission of Documentation for Prequalification of Multisource (generic) FPPs approved by SRAs information on FPPs with WHO, WHO will consider such FPPs for inclusion in the list of WHO prequalified products, as and when information about such products becomes available to WHO and when the applicants in question express their interest in being prequalified by WHO.

The WHO Prequalification Programme wants to establish good-quality medicines for everyone. In close cooperation with national regulatory agencies and partner organisations, the Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

Its strategy is to apply unified standards of acceptable quality, safety and efficacy; to comprehensively evaluate the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites; to prequalify quality-control laboratories of pharmaceuticals; to build the capacity of staff from national regulatory authorities, quality-control laboratories, and from manufacturers or other private companies, to ensure medicines quality.

The key output of the Prequalification Programme is the list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health, which is used principally by United Nations agencies – including UNAIDS and UNICEF – to guide their procurement decisions. But, the list has become a vital tool for any agency or organisation involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the Global Fund to Fight AIDS, tuberculosis and malaria.

Source: WHO

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