The Chilean Public Health Institute (ISP) has issued Resolution Exenta No. E679/2025, establishing an internal procedure for the application of a reliance mechanism in the granting of marketing authorizations for biological pharmaceutical products.
This mechanism will allow products approved by at least two high-surveillance regulatory agencies (such as the FDA, EMA, MHRA, among others) to undergo a faster evaluation process in Chile, avoiding duplicate reviews and optimizing registration times.
The new procedure aims to enhance regulatory efficiency, reduce bureaucratic barriers, and facilitate access to biological medicines in the Chilean market.
You can find the complete document at the following link.
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