Mexico · Federal Commission for the Protection against Sanitary Risks · New drugs
Review target
-
Not published
Legal time limit
180 days
regulation
Steps
4
14 requirements
Application fee
MX$198,496
2026
COFEPRIS grants a sanitary registration for a medicine whose active substance has no registration in Mexico. The agency can ask the New Molecules Committee for a technical opinion during the review. The rules set a maximum of 180 days from filing to the decision. A drug, biological drug or other active substance, alone or in combination, contained in a medicine or biological product, that has no sanitary registration in Mexico.
The application and registration of a new molecule medicine is MX$198,496 for 2026.
1. File the application; 2. Review and decision period (180 days); 3. New Molecules Committee opinion; 4. Decision.
Outcome: A sanitary registration valid for 5 years. It can be renewed for 10-year periods. Valid for 5 years.
Legal basis: Ley General de Salud, articles 222 and 376; Reglamento de Insumos para la Salud, articles 2 (XV), 166, 167, 167-bis, 168 and 170
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 from filing set in the regulation since April 2026. When the last day is not a working day, it moves to the next working day. This is a legal limit, not an actual review time. | 180 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Application and registration of a new molecule medicineApplication · 2026 | MX$198,496 |
Other routes in Mexico: Registration of a medicine with active substances and indications already registered, 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 (26 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.