Regulatory Science

Advancing Regulatory Science

The CPTR initiative works closely with regulatory scientists at the FDA, European Medicines Agency (EMA), and other agencies to advance the tools needed to rapidly develop new TB drug regimens. This effort focuses on developing improved testing methods and establishing best development practices for industry to use when evaluating the safety and effectiveness of new products.

CPTR’s Regulatory Science arm focuses on the following areas:

Because the definition of regulatory science and innovative regulatory pathways are needed to accelerate this process, one of CPTR’s overarching aims is to submit the evidence necessary for regulatory authorities (e.g., FDA and EMA) to officially review and designate testing methods as “qualified or fit for use” in drug development. The newly qualified regulatory science testing methods are then made available for use by CPTR’s Drug Coalition, and made public for all scientists and commercial developers to employ.

To undertake the CPTR Initiative’s groundbreaking approaches, participants share data, knowledge, investment, and scientific staff time.

The CPTR Regulatory Science goals include: