Snapshot

The Recognition of the evaluation and approval of final reports of reference regulatory authorities (Exec. Decree 39433-S) pathway has been developed by the of Costa Rica.

This pathway can be used where chemically synthesized drugs, innovative drugs, multi-source pharmaceutical products, biological medicines and biosimilars..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

In cases in which the Ministry applies recognition, the registration process of innovative synthetic products, registration and renewal of biological products and registration or renewal of chemically synthesized medicinal products that must demonstrate therapeutic equivalence, must be resolved within a period of 99 days from the submission of the respective application, and the procedures of post-registration changes requiring study evaluation clinical proceedings will be resolved within 44 working days.