Through Resolution No. 985 dated July 3, 2025, the Ministry of Health has significantly strengthened the regulatory framework applicable to the sanitary registration of pharmaceutical products in Panama. The regulation incorporates 104 new principles actives into the list of those required to demonstrate Therapeutic Equivalence— that is, to prove they are as safe and effective as the designated reference product —as a mandatory condition for obtaining or renewing their sanitary registration. The resolution adds 104 new active principles (APIs) to the list of those that must demonstrate Therapeutic Equivalence (TE) as a mandatory condition for obtaining or renewing their sanitary registration. With this update, the total number of APIs subject to TE requirements now reaches 173, reinforcing a stricter public policy on interchangeability, therapeutic safety, and quality assurance of medicines marketed in the country.
What does this update mean?
From a regulatory perspective, the new resolution imposes additional technical and documentary obligations, requiring early and strategic planning by pharmaceutical companies seeking to maintain market access.
How does this impact your company?
- For products currently under registration process, the resolution grants a term until the next renewal to submit the required Therapeutic Equivalence studies.
- For already registered products expiring within the next year or less, the same condition will apply.
In both cases, failure to submit the TE studies will result in the inability to renew the product’s sanitary registration. The resolution is already in force, as of its official promulgation.
How to respond appropriately?
At SUCRE ARIAS REYES, we have a specialized legal and technical team with extensive experience in sanitary registrations, therapeutic equivalence studies, and regulatory compliance before the National Directorate of Pharmacy and Drugs. We offer comprehensive, clear and efficient support to ensure that your product portfolio complies with the new requirements without setbacks. Additionally, we are available to coordinate personalized meetings or training sessions to review the specific impact of this regulation on your business and define an appropriate action plan. If you would like to access the complete list of the 173 updated APIs, or if you wish to assess the specific impact on your portfolio, we remain at your disposal.
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