Clinical Trials
This phase asks: “Is the treatment safe?”
What is Phase I?
This Mexican authority regulates, evaluates, and authorizes health-related products
What is COFEPRIS?
This GxP ensures quality during manufacturing
What is GMP (Good Manufacturing Practice)?
A drug produced using biological systems.
What is a Biopharmaceutical (Biofármaco)?
These are regulated under NOM-241-SSA1-2018
What are medical devices manufacturing practices?
This document includes title, objectives, hypothesis, sample size, and methodology
What is the Clinical Protocol?
This document authorizes commercialization of a medicine for 5 years.
What is the Sanitary Registration (Registro Sanitario)?
This GxP focuses on reliability and integrity of recorded data.
What is GDocP (Good Documentation Practice)?
This is an official and mandatory document issued by the Mexican Ministry of Health. It establishes the general methods of analysis and the requirements regarding the identity, purity, and quality of drugs, additives, medicinal products, biological products, and other health care supplies
What is FARMACOPEA?
It is an instrument, apparatus, implant, or machine intended to diagnose, cure, treat, or prevent disease, or affect the body's structure/function, without achieving its primary purpose through chemical action or metabolism
What are medical devices?
This document must include risks, benefits, confidentiality, and signatures of the patient and witnesses
What is the Informed Consent Form?
This NOM establishes Good Manufacturing Practices for pharmaceutical industries.
What is NOM-059-SSA1-2015?
This GxP applies to ethical and scientific quality standards for clinical trials.
What is GCP (Good Clinical Practice)?
It is a non-innovative biopharmaceutical product that has been shown to be similar to a reference biopharmaceutical product in terms of its safety, quality and efficacy.
What is a biosimilar?
This class of device might sustain or support life, are implanted, or present an unreasonable risk of illness or injury.
What is Class III Devices?
This phase determines whether the treatment works.
What is Phase II?
This NOM regulates pharmacovigilance installation and operation
What is NOM-220-SSA1-2016?
This GxP is related to laboratory studies before clinical trials.
What is GLP (Good Laboratory Practice)?
It is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
What is generic drugs?
These type of medical devices include pregnancy tests and glucose test strips.
What are Diagnostic Agents?
These types of studies are designed to prevent members of the research team and study participants from influencing the results.
What are double-blind studies?
This is a group that has been formally designated to review and monitor biomedical research involving human subjects.
What is an Institutional Review Board (IRB)?
In GxP, it ensures that data is complete, consistent, and accurate throughout its entire lifecycle
What is Data Integrity?
It is an official authorization issued by COFEPRIS, which is required for the manufacture, import, or marketing of drugs, medical devices, pesticides, and plant nutrients. Following an evaluation of technical documentation, it certifies the product's safety, efficacy, and quality.
What is Sanitary Registration (Registro Sanitario)?
This software is intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
What is software as a medical device?