Why? Pharmacogenomics studies have shown that drug metabolism in Mexican-Hispanic population can be influenced by its genetic makeup
In which cases? Local clinical studies are required by COFEPRIS for:
- New molecules
- Biotech and biocomparable products
- Generic drugs that are not commercialized anywhere else in the world.
- Other cases upon authority request
When? Previous submission and approval of clinical protocol – Have results before submission for registration.
How? When clinical studies are multicentric, Mexican population must be included. The size of the sample size is not specified in regulations; is to be calculated based on incidence of disease.
As a general requirement, clinical studies have to include Mexican individuals. However, this can be discussed with COFEPRIS in a case-by-case basis at the New Molecule Committee. The NMC might request pharmacokinetic studies to evidence not significant differences in safety or efficacy in Mexicans.
In order to discuss this, a written request to meet with the New Molecule Committee must be submitted, (free-style writing, there is no predetermined form or format) including the information available, and indicating that the product is still in development and that you wish to discuss the suitability of the clinical trial plan. In this initial meeting you are also expected to justify the choice of the molecule, the formula, the innovative features of the product, etc.
During the development of the product, there are no limits in the number of meetings with the NMC. Remember that a meeting will be granted 4 to 6 months after sending the request.
Make sure that the CRO with which you are working is aware of and complies with all the relevant ICH Guidelines for clinical trials. The ICH guideline for Good Clinical Practice is especially important. Compliance with these guidelines will guarantee a level of ethics and professionality in the conduction of the study, and will optimize acceptance of your clinical trial by health authorities in many countries around the world.
Last revision: October 2013