The effects of regulation on innovation in Mexican pharmaceutical industry

Home/Policies & Legislation | Posted 09/03/2023 post-comment0 Post your comment

This article analysed the effect of regulation on the innovation processes in the pharmaceutical industry. The research was exploratory in nature and the design used was a case study, corresponding to the development of a new medication for treating diabetes by a Mexican pharmaceutical company [1].

Regulation V13H16

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

Editor’s comment
Readers interested to learn more about biosimilar orphan drugs in Mexico are invited to visit to view the following manuscript published in GaBI Journal:

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

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper in Spanish and/or English to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here

GaBI Journal Citation Impact
2.2 – CiteScore 2021 (calculated on 5 May 2022)
2.5 – CiteScoreTracker 2022 (Last updated on 5 March 2023)

Submit a manuscript to GaBI Journal

Related articles
Nomenclature of biologicals and biocomparables in Mexico

GMP certification requirements in Argentina, Brazil and Mexico

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La adopción exitosa de biosimilares en Europa y EE. UU.

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La adopción exitosa de biosimilares en Europa y EE. UU.

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010