Drug Registration in Mexico

The formal application process starts when a pharmaceutical company takes the compilation of documents known as the application dossier to the COFEPRIS office. The reviewers at the COFEPRIS will read everything very thoroughly and will address any question they might have about the data on the dossier in the form of a letter, commonly called deficiency letter, officially called prevención in Mexico. Deficiency letters are not always issued, and most of them can be avoided by following all the guidelines, submitting complete information, and avoiding common silly mistakes.

If your product falls into the category of ‘new molecule’, you have to request a meeting with the New Molecule Committe before submitting the application.

These are the cases in which you drug will be considered a “New Molecule”

• New drug substances (new in the world or new for Mexico)
• New combinations of drug substances (for Mexico)
• New indications
• Other special cases (e.g. similar biotherapeutic products)

Just a year ago, an average application could take anything between 1 and 4 years to be reviewed and approved. With some key changes implemented lately, such as the pre-revision process by Third Authorized Parties, or the Agreement for Innovation, timelines are decreasing dramatically, to just some months to a year.

The marketing authorization is granted for a period of five years. Submission for registration renewal must be filed at least 6 months before expiry.

Preparing the submission dossier

The structure of the submission dossier will depend on the type of product that it is intended to be registered.

New Molecules

Module I. Legal/Administrative information

Module II. Quality information

Module III. Preclinical studies

Module IV. Clinical studies

Generic drugs

Module I. Legal/Administrative information

Module II. Quality information

Module III. Bioavailability and/or bioequivalence

Vaccines

Module I. Legal/Administrative information

Module II. Quality information

Module III. Preclinical studies

Module IV. Clinical studies

Orphan drugs

Module I. Legal/Administrative information

Module II. Quality information

Module III. Justification of ‘orphan drug’ status

Module IV. Preclinical studies

Module V. Clinical studies

Checklists of documents for each module

Module I. Legal/Administrative information

1. Form.

2. Proof of payment of fee.

3. Sanitary authorization. (licencia sanitaria) If the manufacturing site is located outside of Mexico, provide licence, certificate or other document authorizing the site to the activities related to manufacturing of pharmaceutical products of interest, issued by the competent authority of the country of origin, legalized or apostilled, translated to Spanish by an official translator (perito traductor).

4. ‘Responsible sanitario’ notice.

5. Labeling texts (if applicable).

6. Complete and summarized prescription information.

7. GMP certificate for manufacturing site of API.

8. GMP certificate for manufacturing site of finished product.

9. GMP certificate for manufacturing site of diluent (if applicable).

10. For drug products manufactured outside of Mexico: Certificate of Pharmaceutical Product (CPP) of origin, apostilled or legalized, with official translation (perito traductor). The CPP is a document that certifies that a pharmaceutical product is registered and/or commercialized in a country. Representation letter, assigning the legal representative of the foreing company in Mexico. It is adviced to write a wide power of representation letter, with a minimum validity period of 5 years.

11. Commercial name.

12. Intellectual property information.

13. Information on the waiver for the local manufacturing facility requirement.

Module II. Quality information

1. API

1.1. Manufacturing information

1.2. General information

1.3. Quality control

1.3.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).

2. Excipients and additives

2.1. For new additives, usage safety information

2.2. Quality control

2.2.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).

3. Finished product

3.1. Pharmaceutical development

3.2. Formula

3.3. Manufacturing information

3.3.1. Manufacturing/packaging order, in-process controls.

3.4. Quality control

3.4.1. Monograph

3.4.2. Specifications

3.4.3. Analytical methods and validation reports (if applicable)

3.4.4 Certificates of analysis (CoAs).

3.5 Stability

3.5.1 Stability protocol

3.5.2. Tabulated stability data

3.5.3 Analytical evidence for first and final testing points.

3.5.4 Conclusions

4. Packaging materials

4.1. Description and capacity of primary packaging materials.

4.2. Description and capacity of secondary packaging materials.

4.3. Description, capacity and information of any additional materials or devices.

Module III. Preclinical studies (for new molecules, vaccines, orphan drugs).

1. Preclinical studies

1.1. Pharmacodynamic studies

1.2. Pharmacokinetic studies

1.3. Toxicology

Module IV. Clinical studies (for new molecules, vaccines, orphan drugs).

1. Clinical studies

1.1. Phase I studies

1.2. Phase II studies

1.3. Phase III studies

1.4. Phase IV studies (if applicable)

1.5. For combination of two or more drugs: risk-benefit assessment.

Module III. Bioavailability and/or bioequivalence (for generic drug products)

1. Type of test

1.1. A

1.2. A (3)

1.3. B

1.4. C