2011 International Conference on Family Planning
29 November–2 December 2011
"Constructing the critical path for MPTs: From product development to regulatory approval"
MPTs that address women’s SRH needs—through preventing unintended pregnancies and/or STIs, including HIV—could make a major contribution to global health. MPTs are a unique and specialized subset of what regulatory agencies generally refer to as "combination products" and often do not fit into the discrete categories of drug, device, or biologic generally used by regulators. As such, MPTs can face an uncertain regulatory environment that can serve as a disincentive to investment and an impediment to advancing candidate products. USAID is providing focused support to facilitate research and development, regulatory approval, and, ultimately, introduction of MPTs.
In order to clarify pathways for regulatory review and licensure of MPTs, both in high resource settings [i.e., US Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA)] and in low resource settings, the Population Council conducted a systematic review of key guidance documents to determine whether and how they may apply to MPTs for sexual and reproductive health. We searched through a range of guidance documents and guidelines from the FDA, EMA, and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and identified three documents which address combination drug products.
Because of the novelty and complexity of MPTs for reproductive health, product developers face unique challenges in shepherding them through regulatory channels and bringing them to market. These include: (1) regulatory requirements for combination products are unclear when applied to MPTs; (2) regulatory requirements are not integrated with early MPT candidate development; and (3) there are no current guidelines for MPTs that are combinations of device and drug, and/or vaccine/microbicide combinations in the reproductive health arena.
Regulatory guidance for the development of MPTs could help sponsors target their efforts, and anticipate timelines and resources needed to carry out product development activities. Product developers must negotiate scientific and technical dimensions along the critical path from innovation to commercial product. Three key elements of the critical path defined by regulatory agencies include: assessing safety, demonstrating medical utility, and industrialization. Equally important elements in delivering the product to the end user include: ensuring regulatory approval at global and country levels, establishing licensing and distribution challenges, developing markets, negotiating financing and procurement mechanisms, generating demand, and fostering an enabling policy environment.
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