Approval routes, expedited programs and designations, with steps, official time targets, fees and reliance. Last verified October 3, 2026.
Routes on this page
15
Reviewed
Product types
7
Drugs, devices and more
Shortest review target
-
Approvals in the data
0
Official regulator data
Mexico has 15 reviewed approval routes and programs on this page. The main routes for new medicines are Registration of a medicine with a new molecule, Registration of a medicine with active substances and indications already registered, Registration of an innovative biotechnology medicine.
Yes. Abbreviated reliance route for medicines relies on BR, CA, CH, EU, JP, US, WHO; Abbreviated reliance route for medical devices relies on AU, BR, CA, CH, CN, EU, GB, JP, KR, RU, SG, US.
4 routes
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.
Full application, new active substance · verified October 3, 2026
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.
Full or mixed application, known active substance · verified October 3, 2026
Herbal, homeopathic and vitamin medicines have a shorter registration procedure. The regulation gives the agency 45 days to decide. For homeopathic medicines, no answer in time means the application is approved.
Traditional or herbal registration · verified October 3, 2026
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.
Reliance route, abridged review · relies on BR, CA, CH, EU, JP, US, WHO · verified October 3, 2026
1 routes
COFEPRIS registers biotechnology medicines such as recombinant proteins and monoclonal antibodies. The decision is due within 180 calendar days. The agency may ask once for missing information during the first 120 days. If no decision is issued in time, the application counts as denied.
Full application, new active substance · verified October 3, 2026
1 routes
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.
Biosimilar application · verified October 3, 2026
1 routes
A generic medicine has the same active substance, dosage form, strength and route as the reference medicine and proves equivalence through interchangeability tests. The decision is due within 180 calendar days. The patent office checks patents in parallel.
Generic application · verified October 3, 2026
1 routes
There is no separate registration route for nonprescription medicines. They get a sanitary registration as allopathic medicines. The law sorts medicines into sale groups, including medicines sold without a prescription only in pharmacies and medicines that can be sold in other stores.
Non-prescription application · verified October 3, 2026
1 routes
Vaccines use the same medicine registration procedure as other allopathic medicines, plus the standards for biological products. Before sale or distribution, each lot needs prior authorization based on laboratory results.
Other route · verified October 3, 2026
6 routes
COFEPRIS can register a medical device already authorized by a regulator that sits on the management committee of the International Medical Device Regulators Forum. The agency checks that the file is complete and decides within 30 working days.
Reliance route, abridged review · relies on AU, BR, CA, CH, CN, EU, GB, JP, KR, RU, SG, US · verified October 3, 2026
Class I devices need a sanitary registration unless they are on the list of exempt low-risk devices. The regulation gives COFEPRIS 30 days to decide. If it does not decide in time, the application counts as approved.
Device: registration or licence with the regulator · verified October 3, 2026
Class II devices need a sanitary registration. The regulation gives COFEPRIS 35 days to decide. A favorable report from an authorized third party shortens this to 15 days.
Device: registration or licence with the regulator · verified October 3, 2026
Class III devices need a sanitary registration. The regulation gives COFEPRIS 60 days to decide. A favorable report from an authorized third party shortens this to 15 days.
Device: registration or licence with the regulator · verified October 3, 2026
Devices on the official list of low-risk devices that still need registration use a short file and a decision within 20 working days. COFEPRIS can ask once for missing information.
Device: registration or licence with the regulator · verified October 3, 2026
Devices on the official list of low-risk devices that do not need registration can be made, sold and distributed without a sanitary registration. They still must meet good manufacturing practice and technovigilance rules. Imports need no import permit, but the importer files a sworn statement at customs.
Device: exempt or self-declared · verified October 3, 2026
Recent changes and pending reforms
Compare Mexico with: United States, European Union, United Kingdom, Japan, China, Germany, France, Italy.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.