Mexico · Federal Commission for the Protection against Sanitary Risks · New drugs
Review target
-
Not published
Legal time limit
45 working days
regulation
Steps
4
6 requirements
Application fee
-
COFEPRIS can register a medicine already approved by a reference regulator. The product must be identical to the approved one. The agency checks only that the file is complete and decides within 45 working days. The registration has the same legal effect as one from the ordinary route. New molecules, generics, innovative and biocomparable biotechnology medicines, biological products and vaccines that a reference regulator approved through its ordinary route in the last 5 years.
1. File the reliance application; 2. Completeness check and decision period (45 days); 3. New Molecules Committee opinion (15 days); 4. Decision.
Yes. It relies on approvals from Brazil, Canada, Switzerland, European Union, Japan, United States, World Health Organization programs (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: A sanitary registration with the same legal effect as one granted through the ordinary procedure. Valid for 5 years.
Legal basis: Reglamento de Insumos para la Salud, article 161 Bis; general guidelines for the abbreviated regulatory route of July 2025
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 45 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 to issue the decision. It is a legal limit, not an actual review time. | 45 working 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 medicine with active substances and indications already registered, Registration of a generic medicine, Registration of an innovative biotechnology medicine, Registration of a biocomparable (biosimilar) medicine, Registration of a vaccine and lot release, Registration of herbal, homeopathic and vitamin 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 (27 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.