Public Health Institute approves new Guideline for Post-Authorization Safety Studies on Pharmaceuticals

Back to All Thought Leadership

The Public Health Institute (“ISP”) approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the “Guideline”).

This arises as an attempt to overcome the current regulatory gap caused by the lack of recommendations that provide concepts or technical guidelines allowing the development of this type of studies for registered products in Chile with well-defined therapeutic indications.

The purpose of this kind of studies is to confirm whether the…

Read more

Sign In

[login_form] Lost Password