Peru Pharmaceuticals

Peru has enacted Law 32319, a landmark regulation aimed at accelerating access to high-quality medications and biological products. Published on May 1, 2025, this law introduces an expedited registration process of up to 45 days for pharmaceutical products originating from high health surveillance countries, such as the United States. The law is particularly focused on drugs treating rare diseases, orphan conditions, and cancer, among others, and represents a critical step toward improving timely and equitable healthcare access in Peru.

The new regulation establishes key procedural benefits for eligible products. These include a streamlined review process, positive administrative silence (automatic approval if no response is issued within the deadline), and exemption from certain regulatory hurdles under Peru’s existing pharmaceutical law. To qualify, U.S. exporters must provide documentation aligned with the Common Technical Document format, a certificate of free sale, risk management plan, and Spanish-language labeling, among other requirements. Notably, the law applies to products designed for climatic zones IV-A or IV-B, consistent with World Health Organization standards.

This legal reform is a major opportunity for U.S. pharmaceutical and biotech companies to bring FDA-approved treatments to the Peruvian market more rapidly. With regulatory timelines cut significantly, Peru now offers a more predictable and business-friendly environment for life sciences firms seeking international expansion. U.S. companies are well-positioned to leverage this opportunity by partnering with local stakeholders, addressing public health needs, and helping close critical treatment gaps across the country.

For further information, please contact CS Peru Commercial Assistant Laura Robinson