2023-09-29 02:00:11
The main objective of the pharmaceutical industry is to research, discover and develop new medicines.
With this new change by Cofepris, studies carried out abroad to register generic medicines in Mexico are now recognized.
The decision to provide new regulatory facilities is to improve and expand the therapeutic offer in the country.
In a surprise decision, the Federal Commission for the Protection against Health Risks (Cofepris) implemented modifications to the Official Mexican Standard (NOM) 177-SSA1-2013 in order to expedite the registration of generic and biosimilar medications.
This standard establishes the criteria for the development of clinical tests in order to demonstrate that a generic and biosimilar medicine has similar efficacy to that of an innovator.
Cofepris implemented changes with the aim of eliminating technical obstacles to the registration of this type of medicines in Mexico. Recognizes studies conducted in countries with criteria equal to or higher than those of Mexico, with health authorities accredited by the World Health Organization (WHO) as reference instances.
New legal provisions
In this first stage, the biosimilar medicines They must still present the results of studies carried out in the country during the extension of the health registry because adjustments are still required to be made in the Regulation of Health Supplies (RIS) to eliminate this requirement, within the framework of the Regulatory Certainty Strategy for the Pharmaceutical Sector.
Likewise, work is being done to comprehensively modify the standard to establish clear rules, mainly for the conduct of clinical studies focused on demonstrating the effectiveness of biosimilar medications.
Cofepris authorizes 22 new generic medicines and one innovative medicine: From oncology to one for HIV
The Commission ensures that these adjustments positively impact both foreign manufacturing companies and Mexican companies that acquire licenses for the manufacturing and marketing of pharmaceutical products. During the registration process, studies carried out in the country of origin will be recognized, as long as its health authorities are accredited as a reference by the WHO.
With this measure, Mexico also advances in the implementation of reliance (harmonization process through which local regulations are aligned with international standards or requirements) in favor of the population, since there are regulatory facilities to continue expanding the therapeutic offer, both of medications of chemical synthesis, such as biosimilar drugs, used as cutting-edge treatments in the care of diseases such as cancer or diabetes.
Differences between generic drugs and biosimilars
Los generic medicines They are drugs that contain the same active ingredient, in the same quantity and pharmaceutical form as an innovative medicine, but that have been developed once the patent on the original has expired.
On the other hand, the biosimilares They are biological medicines that are similar in quality, safety and effectiveness to an innovative biological or biotechnological medicine.
The main difference between a generic drug and a biosimilar lies in its origin and molecular complexity. Generic medicines are usually derived from synthetic chemicals, while biosimilars are highly complex in contrast to a chemically synthesized medicine, as they come from living organisms such as cells or tissues. Therefore, these must be subject to more demanding regulatory requirements regarding approval and post-marketing surveillance.
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