Mexico · Federal Commission for the Protection against Sanitary Risks · Biosimilars
Review target
-
Not published
Legal time limit
180 days
regulation
Steps
5
7 requirements
Application fee
-
A biocomparable medicine is compared with a reference biotechnology medicine through quality, preclinical and clinical studies. The decision is due within 180 calendar days. The agency may ask once for missing information in the first 120 days. No decision in time counts as a denial. A non-innovative biotechnology medicine that uses an innovative biotechnology medicine as its reference.
1. File the application; 2. Review and decision period (180 days); 3. Answer to the information request; 4. New Molecules Committee opinion; 5. Decision.
Outcome: A sanitary registration valid for 5 years, renewable for 10-year periods. Valid for 5 years.
Legal basis: Ley General de Salud, article 222 Bis; Reglamento de Insumos para la Salud, articles 177 Bis 2 to 177 Bis 5
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 280 days end to end with the official step targets, of which up to 100 days are clock stops (time the applicant uses to answer). 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
| Longest clock stopregulation. Maximum time for the applicant to answer the single information request. | 100 working days |
| Legal time limitregulation. Counted from the day after filing. This is a legal limit, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Mexico: 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.