While the pharmaceutical industry and the global health community have made great strides in advancing drug delivery to people around the world, the varying chemistry, manufacturing, and controls (CMC) regulatory requirements from country to country and procurer to procurer pose a great challenge to the efficient development and delivery of medicines.
To address the situation, the Bill & Melinda Gates Foundation has issued a Request for Proposals for a partner to develop and sustain a routinely updated CMC regulatory requirements database platform for small molecule medical products. The platform will house a database of CMC regulatory information from specified low- and middle-income countries, affording much easier access to this information for product developers, regulators, procurers, and others interested in global health. The aim of this RFP is to establish a long-term, sustainable database of CMC regulatory requirements so that the foundation’s product development partners and others can optimize their product development plans and regulatory strategies, thus accelerating product introduction.
The partner chosen through this call for proposals will be expected to translate a preliminary database into an interactive, dynamic, searchable, and user-friendly Web-based platform; maintain the database and ensure that the information is kept up-to-date; and have or design a financially self-sustaining business model.
To be eligible, applicants organization must be open to collaboration; committed to underserved markets; open to a no- or low-cost model for nonprofits and no-cost model for national/regional regulatory authorities, the World Health Organization, and the Gates Foundation; and be able to demonstrate good financial health.
For complete program guidelines, an FAQ, and proposal instructions, see the Gates Foundation website.