The information was primarily collected through semi-structured interviews with personnel from different areas of the company who participated in the drug innovation project. To understand the effect of regulation, the analysis started with the regulatory requirements that the company had to satisfy in each stage of the drug development, from the Research and Development (R & D) phase to the commercialization phase, including cross-functional pharmacovigilance activities.

From the analysis of the different stages of the innovation process, it was found that the majority of the effects are concentrated in three stages: (i) the stage where human beings are involved in the development of tests (clinical trial stage); (ii) the health registration stage, where it is verified that the medicine to be marketed meets safety, efficiency and quality conditions; and (iii) the manufacturing stage, to ensure the appropriate manufacture of the medicine according to good practices.

The findings demonstrate that regulation generated both positive and negative effects. Among the positive effects, the regulation on intellectual property and medication quality stands out. In the case of intellectual property, regulation had a positive effect because it served as an incentive for the company to invest in R & D, as obtaining a patent ensures that generics medications will not compete in the market during the protection period. On the other hand, in the quality of medicine, the positive effect is evidenced in the protection and care of patients through regulatory requirements.

The main negative effects are related to the implementation of regulation, rather than the demands it imposes. Throughout the innovation process, regulation caused delays in planned activities, leading to cost overruns, loss of competitiveness, and uncertainty about the return on investment.

Conflict of Interest
The authors of the research paper [1] did not provide the conflict of interest statement.

Abstracted by Henry Mora Holguin, Doctor en Ciencias Sociales por la Universidad Autónoma Metropolitana de México, Observatorio Colombiano de Ciencia y Tecnología, Carrera 15 # 37-59, Teusaquillo, Bogotá, Colombia

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Readers interested to learn more about biosimilar orphan drugs in Mexico are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico

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Reference
1. Holguín HM, Bielous GD, Vera-Cruz JAO. Regulación e innovación: efectos en la industria farmacéutica mexicana. Braz J Business. 2022;4(4):2058-81.

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