Ask The Mousecid

1. I am interested to know if any food product showing health benefits must have the approval of COFEPRIS to be marketed. Thank you!

Brenda Martinez, Food Chemistry student at La Salle, Mexico City

A. Dear Brenda, thank you very much for your question, it is certainly a very interesting question. Let me tell you, for the registration of food it is not necessary to check its efficacy or safety, as is the case with medicines. However, I recommend that if at any time you plan to use efficacy to promote a product, it is important that you generate safety and efficacy data for it. A short research study can tell you a lot about it.

As such, this research project must be submitted to the Ethics, Research, and Biosafety Committees, before being sent to COFEPRIS. Remember that investing in research to know how effective the product is and to fully understand its safety profile translates into data that represents a competitive advantage in the market.

2. When a product in development presents too many problems to prove its effectiveness, what is considered better, to go ahead and modify it as necessary, even if a lot is invested, or is it better to discard it? At what point should the development of that product be given up?

Debanhi Garcia V., Physician-Surgeon at UJED, Faculty of Health Sciences

A. Within product development, problems in demonstrating efficacy are the most common. In this case, I can recommend that you check if the questions were properly asked: what are we looking for to demonstrate efficacy? Are the biomarkers correct? Is the ADME system known? Do we know the needs of patients and build the efficacy we are looking for in them? Once you answer these questions, you’ll know if you’re looking for the right efficacy of your product.

If not, then I recommend that you modify the product to achieve the effectiveness you are looking for, it is best to understand where it is not working and change it.

Remember that you will have to prove the efficacy of your product to obtain the corresponding authorizations from the regulatory bodies where you are seeking approval. Finally, I think the time to give up on the product comes when you consider the size of the market you would like to reach, taking 1% of the market value, which is what you could potentially access. Once you make your financial runs by reviewing the costs of development, manufacturing, advertising, marketing, and sales processes, you’ll realize how far you can continue to look for product effectiveness.

Best of luck! We hope you tell us more in the future.

3. If a drug was validated in a foreign country for its manufacture and sale, can that same drug be sold in Mexico, for example, or must it also be submitted to COFEPRIS from the beginning?

Biochemistry Engineer, Miguel Perez, Instituto Tecnológico de Colima

A. Thank you, Miguel, for your question. Apart from being very good, it has an incredible complexity, I’ll tell you why. A drug approved in other countries may enter Mexico with documentation and approval for free sale in other countries. I recommend that you review which are the countries in which this type of strategy can be carried out, in any case, the submission of the documentation to COFEPRIS (DOSSIER) must be carried out.

On the other hand, if the country where it is manufactured is not a member of any international

treaty, the drug will be treated as a new registration with COFEPRIS and you will have to demonstrate its efficacy and safety profile through some research studies. In these cases, a lot depends on the type of medication and how much information you have about it.

There are regulatory agents in Mexico who can review the data you have and can guide you on your specific needs.

4. If it is proven that a medical product causes irreparable damage to health, can people sue the company that created it, even if it already has the approval of COFEPRIS and the government to sell it?

Fernanda Garcia, Graduated from Law school at the Faculty of Higher Studies Aragón UNAM

A. Hello, Fernanda, excellent question. Unfortunately, there are several documented cases in which a drug already approved for therapeutic use shows different safety profiles than those demonstrated in clinical trials, these can be severe or non-severe events for the patient’s health.

In these cases, although the pharmaceutical company tries very hard to obtain all the safety data in its clinical studies, it is often not enough. That is why some phase IV studies or extended pharmacovigilance are excellent tools to continue collecting information about the drug once it is already on the market. I recommend that if you know of any adverse event not described on the label of the medication, you immediately notify the telephone numbers that are described on the label of the medication.

5. If a new pharmaceutical product proves to be as effective as an existing drug, can it be validated? If so, would it be worth launching it? Are there already cases of two drugs that are the same?

Benjamin Rodriguez, Metropolitan School of Biochemistry and Pharmacology

A. Thank you for the question, Benjamin. Let me tell you; If within our clinical trials, we demonstrate that there is the same efficacy between two products, I believe that the following questions should be answered: Is its form of administration less invasive? Is it cheaper? Do you need a lower dose for the same therapeutic effect? And how about your adverse events... are they minor? Beyond similar efficacy, we must know what advantages our drug will have in the market compared to the competitor. There are many drugs with similar therapeutic effects but with different advantages, that’s where the decision to launch them on the market lies.

If you have any doubts or new questions, please write to preguntalealratoncid@clirinsider.org

The answers we provide are based on the experience of 15 years of work in Pharmaceutical Research and Development; The comments expressed here are for personal purposes only and are not intended to be a substitute for professional consulting.