Preparing the first regulatory applications for an
HIV prevention ring
As the regulatory sponsor for the dapivirine ring, IPM is pursuing regulatory approval for the ring’s use in countries where women are at high risk of HIV infection. If approved, the ring would be the first microbicide and first vaginal ring licensed for HIV prevention.
In 2016, IPM continued the intensive process of assembling a dossier containing all data on the dapivirine ring for its first regulatory reviews.
IPM plans to submit first to the European Medicines Agency (EMA) through Article 58, a mechanism that provides scientific opinions on products that will be marketed outside of the European Union in low- and middle-income countries, in consultation with the World Health Organization (WHO). A positive opinion from the EMA under Article 58 would help facilitate the ring’s WHO prequalification, which many African regulatory authorities rely on for their own reviews and approvals. IPM also plans to submit applications to the South African Medicines Control Council (MCC) in late 2017, and to the US Food and Drug Administration (FDA) in 2018. First approvals in Africa could come as soon as early 2019.
A peek into the regulatory process
Applying for approval of a new drug like dapivirine involves careful planning and an enormously synchronized effort. Vice President for Regulatory Affairs Patricia Mayer offers some insights into IPM’s approach:
Over the past decade, IPM has generated a tremendous amount of data on the dapivirine ring, from early work to optimize the formulation and nonclinical testing to clinical safety and efficacy. After comprehensive data analyses are conducted, they are compiled into a dossier according to each regulatory agency’s specific application format. The process of assembling the dossier started last year, and is an “all hands on deck” operation as we near our target submission date following a series of meetings with European regulators to ensure we submit as comprehensive a package as possible. After we submit the EMA application, we will immediately start assembling the country-specific applications to the MCC, FDA and each targeted African country.
Only with a committed team will we be able to reach our goal to potentially offer women this promising tool as soon as possible.
IPM meets with African national regulatory authorities from
Ghana, Kenya, Malawi, South Africa, Uganda, Zambia and
Zimbabwe in 2016 in