Mexico · Federal Commission for the Protection against Sanitary Risks · New drugs
Review target
-
Not published
Legal time limit
180 days
regulation
Steps
3
5 requirements
Application fee
-
This route covers medicines whose active ingredients and therapeutic indications are already registered in Mexico, for example a new strength or presentation. The decision is due within 180 calendar days. The active ingredients and the therapeutic indications are already registered in Mexico.
1. File the application; 2. Review and decision period (180 days); 3. Decision.
Outcome: A sanitary registration valid for 5 years, renewable for 10-year periods. Valid for 5 years.
Legal basis: Reglamento de Insumos para la Salud, articles 166 (I) and 167
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 180 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitregulation. Maximum time set in the regulation, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Mexico: Registration of a medicine with a new molecule, Registration of a generic medicine, Registration of herbal, homeopathic and vitamin medicines, Abbreviated reliance route for medicines. See all routes on the Mexico page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.