In accordance with current rules, PiSA® Farmacéutica promotes pharmacovigilance and technovigilance, which include ongoing safety monitoring of our medications and medical devices as well as the detection, assessment, understanding, and prevention of any unintended effects or other issues.
The safety of drugs and medical devices is everyone’s responsibility.

PiSA® Farmacéutica, fostering a reporting culture.

Who participates in pharmacovigilance and technovigilance?

Register Holder or legal representative

Clinical research units.

Institutions and health professionals

Establishments engaged in the sale and supply

Distributors and marketers.

Users or patients


Pharmacovigilance: What is it?

It is a task intended to recognize, quantify, assess, and mitigate hazards associated with drugs or drug products. Its objective is to monitor and evaluate drugs to help guarantee their safe use.

What is a medication side effect?

Also know as an adverse reaction, a medication side effect It is any unintentional response, whether clinical or laboratory, that results from the administration of one or more drugs.
The Pharmacovigilance Unit of PiSA® Farmacéutica governs these activities in accordance with the Mexican Official Standard for the Installation and Operation of Pharmacovigilance, NOM-220-SSA1-2016.

How does pharmacovigilance work?


What is Technovigilance?

These are the steps involved in locating and evaluating adverse events connected to medical equipment. These are medical supplies, which include materials, equipment, mixes of materials, and instruments that can be used singly or in combination for the following purposes:

Diagnosis, monitoring, or prevention of diseases.

Auxiliaries in the treatment of diseases and disabilities.

Replacement, correction, restoration, or modification of human anatomy or physiological processes.

Technovigilance operations enable the identification of risk factors based on adverse incident reports that are communicated, recorded, and assessed. This allows for the determination of the frequency, severity, and incidence of these variables, as well as their prevention and risk minimization.

What is an Adverse Incident?

A verified incident involving the usage of medical equipment. There is unambiguous evidence of a causative association for this, which has the potential to be fatal or seriously worsen the user’s health.

These activities are managed by Laboratorios PiSA® Technovigilance Unit in compliance with NOM-240-SSA1-2012, the Mexican Official Standard for the Installation and Operation of Technovigilance.

How does Technovigilance work?