As part of its efforts to expand access and make certain drugs more affordable for the treatment of a variety diseases and conditions, the World Health Organization is inviting API manufacturers to apply for prequalification.
The organization is hoping to entice more manufacturers of selected APIs to participate in the evaluation and standards qualification process to increase the availability of drugs to treat HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza and diarrhea, as well as support reproductive health.
This year, WHO has added the anti-tuberculosis drug gatifloxacin to its list of APIs, the Regulatory Affairs Professionals Society reported in its online publication.
The assessment by WHO includes evaluating API master files (APIMF) that are required to include data and information outlined in its guidelines. If accepted, the API will be listed by WHO as acceptable for incorporation into finished pharmaceutical products.
“APIs for which an APIMF has already been assessed and accepted by WHO, and the relevant manufacturing site(s) has(have) been inspected by WHO or a Stringent Regulatory Authority in the previous three years and found to comply with WHO GMP requirements for the manufacture of the particular API, may be included in the list without prior reassessment or re-inspection,” the organization said in its invitation.
API manufacturers that wish to take part in the prequalification of APIs should contact the relevant national authorities to collaborate with WHO in the quality assessment process.
by Joseph Keenan |