Drug registration in Mexico is handled by the Federal Commission for Protection against Sanitary Risk (COFEPRIS). The registration route, documentation and review requirements vary according to the type of medicine and the applicable procedure.
This guide explains the COFEPRIS drug registration process in Mexico, including medicine classification, CTD dossier requirements, GMP documentation, submission and review, timelines, fees, and the current regulatory pathways available for pharmaceutical products.
COFEPRIS Role in Pharmaceutical Regulations in Mexico
COFEPRIS is Mexico’s health authority for medicines and vaccines. It is responsible for sanitary authorizations, including medicine registrations, and oversees regulatory activities such as GMP certification, import-related authorizations, advertising authorization and post-market surveillance.
For pharmaceutical products, COFEPRIS reviews registration applications and determines whether a medicine can receive sanitary registration in Mexico. After approval, compliance continues through manufacturing-site surveillance, GMP verification, pharmacovigilance, market surveillance and other post-market controls.
COFEPRIS Drug Classification in Mexico
Before choosing a registration pathway, the product must first be classified correctly.
Under Article 224 of Mexico’s General Health Law, medicines are classified by their method of preparation and by their nature.
| Classification basis | Category | Meaning |
| Method of preparation | Magisterial medicines |
Prepared according to a formula prescribed by a physician
|
| Officinal medicines |
Prepared according to the rules of the Pharmacopoeia of the United Mexican States
|
|
| Pharmaceutical specialties |
Prepared using formulas authorized by the Ministry of Health in establishments belonging to the chemical-pharmaceutical industry
|
|
| Nature | Allopathic medicines |
Natural or synthetic substances or mixtures with therapeutic, preventive or rehabilitative effects, presented in pharmaceutical form
|
| Homeopathic medicines |
Prepared according to procedures described in the Homeopathic Pharmacopoeia of the United Mexican States or other recognized scientific sources
|
|
| Herbal medicines |
Products made from plant material or derivatives, in pharmaceutical form, whose therapeutic efficacy and safety are supported by scientific literature
|
Mexico also classifies medicines according to how they may be sold or supplied to the public. Under Article 226 of the General Health Law, medicines fall into six categories:
- Medicines requiring a special prescription or permit issued by the Ministry of Health.
- Medicines requiring a prescription that must be retained by the pharmacy and recorded in the applicable control books.
- Medicines requiring a prescription that may be filled up to three times, with the prescription recorded each time and retained on the third dispensing.
- Medicines requiring a prescription that may be refilled as many times as prescribed by the physician.
- Non-prescription medicines authorized for sale exclusively in pharmacies.
- Non-prescription medicines that may also be sold in establishments other than pharmacies.
COFEPRIS Drug Registration Process in Mexico
For most medicines, the standard sanitary registration procedure is COFEPRIS-04-030.
It covers nationally manufactured and imported products, including:
- new molecules
- generic medicines
- biocomparables
- innovative biotechnological medicines
- herbal medicines
- homeopathic medicines
- vitamin products
The process can be understood in six main steps.
1. Confirm the Product Category and Registration Pathway
Start by identifying the type of medicine and the applicable registration route.
Products that meet COFEPRIS’s definition of a new molecule may require review by the Comité de Moléculas Nuevas (CMN). This can apply to certain new active substances, medicines not previously registered in Mexico, new combinations and new therapeutic indications.
2. Prepare the Registration Dossier
COFEPRIS requires medicine registration information to be organized according to the Common Technical Document (CTD).
COFEPRIS published CTD Version 3.0 on 27 February 2026. This orientative guidance provides updated recommendations, dossier formats and supporting checklists for organizing medicine and biological-product registration applications.
3. Compile the Administrative and Technical Documentation
The dossier should contain the information applicable to the medicine and application type, including:
- administrative documentation
- prescribing information
- proposed labeling
- quality information
- safety information
- efficacy information
- GMP documentation
- additional product-specific or foreign-manufacturer documents, where applicable
4. Submit the Sanitary Registration Application
The completed application is filed under the applicable COFEPRIS procedure.
For the standard medicine-registration pathway, the procedure is COFEPRIS-04-030.
The official COFEPRIS-04-030 procedure currently lists the application as an in-person submission, beginning with an appointment scheduled through COFEPRIS.
5. COFEPRIS Technical Evaluation
COFEPRIS evaluates the submitted information against the applicable regulatory requirements.
If clarification or additional information is required, the applicant may need to respond to COFEPRIS before the evaluation can be completed.
6. Registration Decision
If the application meets the applicable requirements, COFEPRIS may grant the sanitary registration.
Once approved, the medicine may be marketed in Mexico subject to the conditions of the authorization and applicable continuing regulatory obligations.
After registration, the registration holder must continue to meet applicable requirements relating to areas such as pharmacovigilance, GMP compliance, modifications to the conditions of registration and renewal.
For current requirements, refer to the COFEPRIS-04-030 medicine registration procedure.
GMP Requirements for Drug Registration in Mexico
GMP compliance is an important part of the medicine-registration process.
For medicines, the applicable manufacturing standard is NOM-059-SSA1-2015, Good Manufacturing Practices for Medicines, including its current modifications. COFEPRIS lists NOM-059 as in force, with the latest modification published in March 2025.
For medicines manufactured outside Mexico, COFEPRIS-04-030 requires a GMP certificate or equivalent document for the medicine manufacturer and, where applicable, for manufacturers of the biopharmaceutical, antigen or chemically synthesized active substance.
For chemically synthesized active substances, the certificate may also be issued by the national regulatory authority of the country of origin.
Does Every Foreign Site Need a COFEPRIS Inspection?
No.
A COFEPRIS inspection is not automatically required for every foreign manufacturing site. Where an acceptable GMP certificate or equivalent document is available, it may be submitted as part of the registration dossier.
When a verification visit is required, COFEPRIS uses the COFEPRIS-01-020 sanitary verification visit procedure for GMP certification of medicines and other health supplies manufactured in Mexico or abroad.
COFEPRIS may also conduct verification visits for:
- GMP certification
- sanitary-license procedures
- regulatory follow-up
- sanitary-surveillance activities
For current inspection requirements, refer to the COFEPRIS sanitary verification visit for GMP certification.
COFEPRIS CTD Dossier Requirements for Drug Registration in Mexico
The registration dossier follows the five-module Common Technical Document structure.
A simple way to understand it is:
| Module | What it covers |
| Module 1 |
Mexico-specific administrative and regulatory information
|
| Module 2 |
CTD summaries and overviews
|
| Module 3 | Quality |
| Module 4 | Nonclinical information |
| Module 5 | Clinical information |
Module 1: Mexico-Specific Administrative and Regulatory Information
Module 1 contains the regional documentation required for the Mexican application.
Depending on the medicine and whether it is manufactured in Mexico or abroad, this may include:
- completed FF-COFEPRIS-22
- proof of fee payment
- prescribing information in the applicable versions
- proposed labels and package insert, where applicable
- GMP certificates or equivalent documents
- Certificate of Free Sale or equivalent for foreign-manufactured medicines
- manufacturer representation documentation, where applicable
- documentation supporting a legal representative in Mexico for a foreign registration holder
- other product- and application-specific administrative requirements
- patent information or the applicable declaration of compliance with Mexican patent requirements, where required
- Risk Management Plan (Plan de Manejo de Riesgos), including the corresponding pharmacovigilance programme
These requirements serve different purposes. A foreign holder of the sanitary registration must provide documentation supporting a legal representative domiciled in Mexico, while a manufacturer representation letter applies when the foreign manufacturer is neither the parent company nor a subsidiary of the registration applicant.
Module 2: CTD Summaries and Overviews
Module 2 provides summaries of the quality, nonclinical and clinical information contained in Modules 3, 4 and 5.
Its structure follows the applicable ICH CTD guidance.
Module 3: Quality
Module 3 covers the quality of the active substance and finished pharmaceutical product.
Typical areas include:
- manufacturing
- characterization
- controls
- specifications
- analytical methods
- container-closure systems
- stability
Mexico-specific regional information should be included where required.
Module 4: Nonclinical Information
Module 4 contains the applicable nonclinical study reports, including:
- pharmacology
- pharmacokinetics
- toxicology
The amount of information required depends on the medicine and application type. A full nonclinical package is not generally expected in the same way for generic medicines.
Module 5: Clinical Information
Module 5 contains the applicable clinical evidence supporting the medicine.
For generic medicines, this may include relevant interchangeability or bioequivalence information required under Mexican rules rather than a full new-drug clinical development package.
Applicants should use the current COFEPRIS CTD Version 3.0 guidance when preparing the registration dossier.
Registration Process for Foreign Pharmaceutical Manufacturers in Mexico
Foreign manufacturers should first determine whether the product will follow the standard route or may qualify for the abbreviated reliance route.
| Route | When it generally applies |
| COFEPRIS-04-030 | Standard medicine-registration route |
| COFEPRIS-04-040 |
Eligible medicines with qualifying prior approval from a recognized Reference Regulatory Authority
|
Standard Registration Route
Foreign-manufactured medicines submitted through COFEPRIS-04-030 must provide the applicable foreign-manufacturer documentation.
This may include:
- evidence that the manufacturer is legally authorized to manufacture medicines in the country of origin
- GMP documentation or an accepted equivalent
- product-specific regulatory documentation
- manufacturer representation documentation, where applicable
Where the foreign manufacturer is not the parent company or subsidiary of the registration applicant, a manufacturer representation letter may also be required.
Abbreviated Registration Through Reference Regulatory Authorities
COFEPRIS-04-040 is the current abbreviated pathway for eligible medicines already approved by a recognized Reference Regulatory Authority (ARR).
Key eligibility points: the marketing authorization or equivalent issued by the Reference Regulatory Authority must have been granted within the previous five years. The abbreviated route may not be used where there are changes in the medicine’s quality aspects, manufacturing sites or primary-packaging sites compared with those approved by the Reference Regulatory Authority. Different secondary-packaging sites may be accepted if the applicable legal documentation is provided.
The pathway applies to:
- new molecules
- generic medicines
- innovative biotechnological medicines
- biocomparables
- biological products
- vaccines
For biological medicines, innovative biotechnological medicines and vaccines submitted through COFEPRIS-04-040, COFEPRIS requests a technical opinion from the Comité de Moléculas Nuevas (CMN) as part of the procedure. The CMN has a maximum of 15 working days from the day after submission to issue its opinion.
COFEPRIS may also use evaluations from the WHO Prequalification Programme as part of the abbreviated reliance pathway. For WHO-prequalified medicines, applicants must provide the WHO prequalification reference number and date, and the relevant manufacturing sites must correspond to those listed in the current WHO Prequalified Medicines List.
COFEPRIS uses qualifying foreign regulatory decisions as part of an abbreviated evaluation. However, prior foreign approval does not remove the need to meet Mexican sanitary-registration requirements.
Depending on the authority relied upon, supporting documents may include:
- FF-COFEPRIS-01 application form
- marketing authorization or equivalent
- FDA approval letter and supporting documents, where applicable
- Certificate of Pharmaceutical Product
- Certificate of Free Sale or equivalent
- GMP certificate or equivalent
- prescribing information
- proposed labels and package insert
- applicable pharmacovigilance documentation
- CTD technical-scientific information
The current COFEPRIS-04-040 procedure provides the official eligibility and documentation requirements for this route.
April 2026 Update: COFEPRIS Medicine Registration Viewer
On 22 April 2026, COFEPRIS launched the Medicine Sanitary Registration Viewer, giving the public access to current medicine-registration information. The tool allows users to review details such as registration status, product names, active ingredients, issue and renewal dates, registration holders and manufacturers, and to search registrations using several product- and manufacturer-related criteria.
COFEPRIS also publishes yearly lists of registrations that have been granted, modified, renewed, revoked or cancelled. The Drug Registration Viewer is available from the COFEPRIS medicine registration lists page for searching individual medicine registration details.
Common Challenges in COFEPRIS Drug Registration
Most registration difficulties are easier to understand when grouped into four practical areas.
Keeping Up With Current Requirements
COFEPRIS has updated important parts of the registration framework in recent years, including:
- CTD requirements
- GMP documentation criteria
- abbreviated reliance procedures
Applicants should therefore work from the latest applicable COFEPRIS requirements rather than older submission structures.
Keeping the Dossier Internally Consistent
Information should match across the administrative, quality, nonclinical and clinical parts of the CTD.
Common areas that need consistency include:
- application forms
- manufacturing-site information
- GMP documentation
- prescribing information
- labels
- technical modules
Differences between these documents can result in questions during review.
Managing Foreign-Issued Documents
Certain documents issued outside Mexico may need to be:
- apostilled or legalized
- translated where required
Where documents are in a language other than Spanish or English, the applicable translation requirements must be met.
Some technical documentation may be accepted in English under the current CTD framework, depending on the document type.
Responding to COFEPRIS Requests
COFEPRIS may request clarification or additional information during evaluation.
Clear, complete and timely responses help prevent avoidable extensions to the review process.
COFEPRIS Drug Registration Fees in Mexico
Registration fees depend on the medicine category.
COFEPRIS-04-030 Fees for 2026
| Medicine category | 2026 registration fee |
| Homeopathic, herbal and vitamin medicines | MXN 26,398 |
| Generic and biocomparable medicines | MXN 111,012 |
| New-molecule and innovative biotechnological medicines | MXN 198,496 |
COFEPRIS-04-040 Fees for 2026
| Medicine category | 2026 registration fee |
| Generics and biocomparables | MXN 111,012 |
| New molecules, innovative biotechnological medicines, biological products and vaccines | MXN 198,496 |
The applicable fee must be paid before the registration procedure is initiated.
Applicants should check the current official COFEPRIS procedure before payment because fees are determined according to the medicine category and the corresponding provisions of the Federal Rights Law.
COFEPRIS Drug Registration Timelines in Mexico
The official response time depends on both the registration route and medicine category.
| Registration route / medicine category |
Official response time
|
| COFEPRIS-04-030 — New molecules | 120 calendar days |
| COFEPRIS-04-030 — Generics, biocomparables and innovative biotechnological medicines | 90 calendar days |
| COFEPRIS-04-030 — Herbal, homeopathic and vitamin medicines | 25 working days |
| COFEPRIS-04-040 — Abbreviated ARR pathway | 45 working days |
Sanitary registrations under these routes are valid for 5 years.
Products falling within the scope of the Comité de Moléculas Nuevas (CMN) may require an additional technical-opinion step before or as part of the applicable registration pathway.
The CMN process should not be treated as part of a universal registration timeline because it applies only to defined new-molecule cases and follows its own meeting schedule and opinion process.
When planning the overall project, distinguish between:
- the official COFEPRIS response period
- any separate CMN step that may apply
- dossier-preparation time
- time required to obtain supporting documents
- time needed to respond to COFEPRIS information requests
Conclusion
Drug registration in Mexico requires more than submitting a dossier to COFEPRIS.
Applicants need to:
- identify the correct medicine category
- select the applicable registration pathway
- prepare the current CTD structure
- provide the required GMP and manufacturing documentation
- submit the applicable COFEPRIS procedure
- respond to regulatory questions during evaluation
- maintain compliance after registration
For most medicines, the standard route is COFEPRIS-04-030. Eligible products with qualifying prior approval from recognized Reference Regulatory Authorities may instead qualify for the abbreviated COFEPRIS-04-040 pathway.
The correct route, documentation, fee and timeline therefore depend on the medicine and its regulatory status.
Artixio supports pharmaceutical companies with COFEPRIS registration strategy, dossier preparation, regulatory submissions and ongoing compliance in Mexico. Explore our pharmaceutical compliance and registration services in Mexico.
FAQs
1. What is COFEPRIS in Mexico?
COFEPRIS is Mexico’s federal health regulatory authority. For medicines, it handles sanitary registration and other regulatory activities relating to manufacturing, imports, advertising, pharmacovigilance and post-market compliance.
2. How does the COFEPRIS drug registration process work?
The process begins by identifying the medicine category and applicable registration pathway.
Applicants then:
- prepare the CTD dossier
- compile the required administrative and technical documentation
- submit the sanitary registration application
- respond to any COFEPRIS information requests
- receive a registration decision after technical evaluation
The standard procedure is COFEPRIS-04-030. Eligible medicines with qualifying prior approval from recognized Reference Regulatory Authorities may use COFEPRIS-04-040.
3. How long does drug registration take in Mexico?
The official response period depends on the medicine category and pathway:
- 120 calendar days for new molecules under COFEPRIS-04-030
- 90 calendar days for generics, biocomparables and innovative biotechnological medicines
- 25 working days for herbal, homeopathic and vitamin medicines
- 45 working days under the abbreviated COFEPRIS-04-040 pathway
These are official regulatory response periods and do not include dossier preparation or other applicable pre-submission activities.
4. Can a medicine already approved by another regulatory authority use an abbreviated pathway in Mexico?
Potentially.
Medicines that meet the applicable eligibility criteria and have qualifying approval from a recognized Reference Regulatory Authority may be submitted through COFEPRIS-04-040.
Prior foreign approval does not automatically guarantee eligibility or approval in Mexico. The product must still meet the applicable Mexican sanitary-registration requirements.
5. Where can COFEPRIS medicine registrations be checked?
COFEPRIS publishes official medicine registration records, including registrations that have been granted, modified, renewed, revoked or cancelled. Individual medicine registration details can also be searched through the Drug Registration Viewer, available from the COFEPRIS medicine registration lists page.
