Developing regulatory guidelines for a category of drugs that does not yet exist is a daunting problem for any country. For resource-poor nations, where HIV is most prevalent, it is particularly difficult.

IPM is working with national and international experts in order to identify expedited regulatory strategies, and address regulators’ concerns preemptively in order to ensure that licensure is not unnecessarily delayed.

In 2007, IPM convened a meeting, which included a discussion among regulatory and other experts from several African countries on regulatory challenges and opportunities within the region for microbicides.

IPM is also strengthening global regulatory capacity on microbicides. It has teamed with the World Health Organization to convene regulators from developing countries to discuss and address their concerns. It is creating stronger links between regulatory authorities worldwide for joint reviews of products, and working with the United States Food and Drug Administration and the European Medicines Evaluation Agency to facilitate approvals for use in developing countries.

>> View or download June 2004 article from Science on “Regulatory Challenges in Microbicide Development” (June 2004)