Mexico Drug Registration Process

Bioequivalence and Biocompatibility Studies

• Emergency Modification to NOM-177-SSA1-2013 (May 3, 2021):
  • COFEPRIS issued an emergency modification to NOM-177-SSA1-2013, addressing bioequivalence and bio-comparability studies.
  • The one-year regulatory change allowed the health authority to recognize bioequivalence studies conducted abroad, streamlining the sanitary registration process for generic drugs in Mexico.
  • The regulatory committee of COFEPRIS voted to permanently integrate the emergency modifications into NOM-177-SSA1-2013.
• Publication of Permanent Modification:
  • The permanent modification to NOM-177-SSA1-2013, reflecting the emergency changes, is set to be published in the Official Journal of the Federation in the first quarter of 2023.
• Guaranteeing Recognition of Studies Conducted Abroad:
  • COFEPRIS aims to ensure the full recognition of bioequivalence and bio-similarity studies conducted in countries with criteria equal to or higher than Mexico.
  • Integration of the bio-exemption figure, as promoted by organizations like ICH or WHO, will be included in the National Quality Infrastructure Program 2023 Supplement.
  • An exhaustive modification of NOM-177 is anticipated, with results likely to be reflected in 2024.

Entry of Foreign-Manufactured Biotechnological Drugs

• Regulatory Requirement:
  • According to TNOM-059-SSA1-2015, Good Manufacturing Practices for Medicines, foreign companies producing biotechnological products must have a GMP issued by the health authority of the importing country for entry and commercialization.
  • This requirement is considered a technical barrier to trade and contradicts the Global Reliance for Pharmaceutical Good Practices (GRelP), which recognizes GMPs of PIC/S member countries for sanitary registration.
• Proposed Modification:
  • In response to this issue, the institution plans to make an emergency modification to NOM-059-SSA1-2015 in the first quarter of 2023.
  • The modification aims to eliminate the commercial barrier, allowing the entry and release of batches of non-vaccine biotechnological drugs for companies with GMP from a High Surveillance Regulatory Agency and other quality certification documentation, in alignment with PIC/S and WHO regulations.
• Accompanying Measures:
  • The modification will be accompanied by the strengthening of the Post-Marketing Surveillance Program (PVPC).
  • This aims to simplify the process of releasing batches of biotechnological products and enhance the capacity to detect health risks during the sale and distribution of pharmaceutical products.
• Integration into National Quality Infrastructure Program:
  • Cofepris commits to integrating NOM-059 into the Supplement to the National Quality Infrastructure Program 2023.
  • This move aims for a permanent modification of the technical standard, aligning it with international practices and regulations.

Biologics and New Drug

Preparation and Documentation:

Module I. Legal/Administrative information

1.   Proof of payment of fee.
2. Sanitary authorization. (licencia sanitaria) If the manufacturing site is located outside of Mexico, a statutory or declared license or certificate issued by the competent authority of the country of origin authorizing the site to carry out activities related to the production of covered medicinal products. Documentation., translated into Spanish by an official translator (Perito traductor).
3. ‘Responsible sanitario’ notice.
4. Labelling texts (if applicable).
5. Complete and summarized prescription information.
6. GMP certificate for manufacturing site of API.
7. GMP certificate for manufacturing site of finished product.
8. GMP certificate of the place of production of the diluent (if any).
9. For drugs manufactured outside of Mexico: Certificate of Pharmaceutical Product (CPP) with official translation (Perito traductor). CPP is a document that certifies that a medicinal product is registered and/or commercialized in a country. Letter of representation appointing the legal representative of a foreign company in Mexico.
10. Commercial name.
11. Intellectual property information.
12. 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/Pharmacopoeia 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/Pharmacopoeia 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.

Registration Timeline

1 to 4 years

Registration Fee

• Full MMA: TRY 100,000 – TRY 500,000 (approx. USD 5,000 – USD 25,000)
• Conditional MMA: TRY 50,000 – TRY 250,000 (approx. USD 2,500 – USD 12,500)
• Import Permit for Clinical Trials: TRY 10,000 – TRY 50,000 (approx. USD 500 – USD 2,500)

License Validity

5 Years.