Reliance mechanism for the sanitary registration of biological pharmaceutical products

On February 5, 2025, the Institute of Public Health of Chile (ISP) published the Exempt Resolution No. E6792025 establishing that the reliance mechanism will apply when requested by the applicant.

The resolution aims to implement an accelerated registration procedure, reducing processing costs and improving access to medicines. This mechanism exempts the submission and review of certain documents if they have already been evaluated and approved by high-surveillance regulatory agencies.

“This document does not constitute legal advice and the Guerrero Olivos studio will not be responsible for acts or omissions of third parties based on the information contained in it.”