- info@ddregpharma.com
- DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
-
USA
-
India
-
Germany
-
Singapore
The CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act is a U.S. federal law passed in 2019 designed to promote competition in the pharmaceutical industry by addressing anti-competitive practices that delay the entry of generic drugs and biosimilars into the market. The Act specifically targets situations where brand-name drug manufacturers refuse to provide the necessary samples of their products to generic and biosimilar developers, which are essential for conducting bioequivalence or biosimilarity testing required for FDA approval.
It also prevents brand companies from exploiting Risk Evaluation and Mitigation Strategies (REMS) programs as a pretext to deny access to these samples, ensuring that safety protocols are upheld without stifling competition. If the requested product is governed by a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), one crucial step is obtaining a Covered Product Authorization (CPA) from the FDA. However, this requirement does not apply to products not subject to REMS with ETASU.
The CREATES Act is a transformative step in promoting fairness and competition in the pharmaceutical industry. Addressing anti-competitive practices and facilitating the entry of generics and biosimilars brings affordable medications closer to those who need them most. At DDReg, we understand the intricacies of the CREATES Act and its impact on the global pharmaceutical landscape. Our seasoned experts assist in navigating the CREATES Act's provisions, ensuring compliance and strategic advantage.