In our blog titled "Types of Medicines" (https://bit.ly/3qMJ9nv) we met the medicines called "Alopathic" which today predominate in the Mexican market, so at this time we will address them again since For your request for Sanitary Registration, our Sanitary Authority (COFEPRIS) classifies them into New Molecule Medicine and Generic Medicine, this classification is extremely important since it defines the basis of the regulatory framework and the technical-scientific information that must be presented to guarantee its quality, safety and efficacy.
The first point that we will address are the definitions of medicine, new molecule, new molecule medicine categories, as well as generic medicine which will allow us to understand the differences that exist between this type of medicine and finally we will also know the general requirements for its registration.
Definitions
Medication: Any substance or mixture of substances of natural or synthetic origin with therapeutic, preventive or rehabilitative effect, presented in pharmaceutical form and identified as such by its pharmacological activity, physical, chemical and biological characteristics. When a product contains nutrients, it will be considered as a medicine, provided that it is a preparation that contains individually or in association: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher than those of natural foods and it is also presented in a defined pharmaceutical form and the indication for use contemplates therapeutic, preventive or rehabilitative effects.
New Molecule: a substance of natural or synthetic origin that is the active ingredient of a drug, not previously used in the country, whose efficacy, safety and therapeutic purposes have not been fully documented in the scientific literature.
New molecule medicines are those corresponding to the following categories:
Generic Medicine: to the pharmaceutical specialty with the same drug or active substance and pharmaceutical form, with the same concentration or potency, that uses the same route of administration and that through the required regulatory tests, has verified that its pharmacopoeial specifications, dissolution profiles or its bioavailability or other parameters, as the case may be, are equivalent to those of the reference medicine.
General Requirements for the Sanitary Registry
In the following table we present the General Requirements for the Sanitary Registration of a New Molecule Medicine and a Generic Medicine in accordance with the current regulatory framework.
Finally, we can conclude that the characteristics of the Sanitary Registration request defined for each type of medicine have a specific regulatory framework that manufacturers must comply with in order to demonstrate the quality, safety, and efficacy of the medicines before reaching the population.
If you are in the process of registering a New Molecule or Generic Medications and you have doubts about the characteristics or requirements to present, call us, we can advise you or help you put together the dossier for the application of your Sanitary Registration.
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