Over the past year, Venture Strategies has been steadily working with the Tanzanian government towards registering the drug misoprostol to control postpartum hemorrhage (PPH). Since our Medical Director's groundbreaking operations research demonstrating misoprostol is safe to use at home births in Tanzania, and substantial policy and advocacy efforts, this lifesaving drug is poised for registration pending approval of the regulatory dossier.
To date we have facilitated a partnership between a high quality generic pharmaceutical manufacturer and a Tanzanian distributor, ByTrade, to submit the regulatory application to register and import misoprostol for use in controlling PPH. Additionally, Venture Strategies and our colleagues at the School of Public Health, UC Berkeley provided technical expertise to draft the regulatory dossier, which has been submitted to the Tanzanian Food and Drug Authority.
In preparation for misoprostol's forthcoming regulatory approval, we are co-hosting an expert technical meeting in October 2007 to discuss the integration of new misoprostol clinical guidelines and plans for implementation of misoprostol at the community level.
In the year since Dr. Ndola Prata published her landmark study demonstrating that misoprostol can be used safely and effectively to save mother's lives from excessive bleeding after childbirth by illiterate traditional birth attendants, significant strides have been made towards making this life-saving drug available to all Tanzanian women who die needlessly in childbirth.
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