PXL/HO/Cir-017/2021-22                                                                                         Date: 20.05.2021

Hyderabad

Dear Sir/Madam,

Subject: New guidelines by the Health registration authority of Mexico (COFEPRIS)

We are glad to inform our member companies that the Mexican health regulatory authority, COFEPRIS has amended their rules and regulations governing the registration of health products establishing interchangeability and bioequivalence in the registration of products on 3^rd May, 2021.

The regulatory authority has amended the regulations due to the health emergency caused by the SARS-CoV2 (COVID-19) virus affecting the whole world as a measure to deal with the shortage of medicines amidst this pandemic. This recent emergency modification eliminates the obligation of interchangeability testing for foreign laboratories, and they will be able to bring their drugs tested anywhere in the world. As a result, it will be possible to import medicines with or without health registration that are authorized by international regulatory authorities, to Mexico.

According to COFEPRIS, the new norm establishes the rules for conducting bioequivalence studies and indicates that the interchangeability of generic medicines must be demonstrated by scientific evidence. The amendment published in the Official Federal Gazette on 3^rd May, 2021 modifies six important points as follows:

1. This standard is mandatory throughout the national territory for those performing tests to demonstrate interchangeability and for those performing tests to demonstrate bioequivalence, may be performed in Mexico when so determined by the New Molecules Committee of the Ministry of Health.

2. Interchangeability testing, when carried out in the national territory, shall be performed by Authorized Third Parties. In the case of foreign manufactured medicinal products, interchangeability of bioequivalence studies carried out in the country of origin shall also be acceptable, and interchangeability tests carried out by Authorized Third Parties in the national territory with Mexican population shall be submitted in their extension.

3. Interchangeability tests carried out abroad may be recognized, provided that:

• The establishments where they are carried out are authorized by the country of origin.

• The technical criteria for the performance of the tests have used as a reference, one of the guidelines listed below:

• Agencia Nacional de Vigilancia Sanitaria. Resolucao DRC No. 27 Dispoe sobre os requisitos mínimos para a validacao de métodos bioanalíticos empregnados em estudos com fns de registro e pós-registro de medicamentos. 17 Maio 2012
• European Medicines Agency. Science Medicines Health. Guideline on the investigation of bioequivalence. 20 Jan 2010.
• European Medicines Agency. Science Medicines Health. Guideline on bioanalytical method validation. 21 Jul 2011.
• FDA, Guidance. Statistical Approaches to Establishing Bioequivalence. Jan 2001.
• Health Canada. Guidance Document. Conduct and Analysis of Comparative Bioavailability Studies. 08 Feb 2012.
• ICH E3 Harmonised Tripartite Guideline Structure and Content of Clinical Study Reports.
• ICH E6 (R1) Good Clinical Practice: Consolidated Guidance.
• ICH E8 Harmonised Tripartite Guideline General Considerations for Clinical Trials.
• ICH E9 Harmonised Tripartite Guideline Statistical Principles for Clinical Trials.
• Annex 6 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series 1003. Fifty-first report 2017.

4. In case there are changes in the production process that modify the physical, chemical, structural or biological properties of the test, tests as determined by the New Molecules Committee of Mexico must be performed.

5. This Committee will evaluate the pre-clinical protocols and may request the extension of pre-clinical testing when it considers it appropriate for national products

6. In the case of innovative biotechnology products or bio-comparable of foreign origin, the New Molecules Committee may request the extension of pre-clinical testing when it deems it appropriate. In the case of medicinal products with sanitary authorization by some of the Regulatory Agencies recognized by COFEPRIS, the Committee may or may not request the extension of clinical trials.

These changes in the rules governing pharmaceutical products in Mexico will pave the way for increased volume of exports and opportunities of direct sourcing of the required products from India. 

Member companies are requested to take note of this important regulatory update for their future product registrations and exports to Mexico.

With regards,

Uday Bhaskar

Director General