overview of pharmacovigilance requirements in mexico · 2020. 12. 15. · it is compatible with the...

Overview of Pharmacovigilance Requirements in Mexico

December 15, 2020

PV Authorities in Mexico Definitions of PV terms PV Objectives PV Regulations Means of notification of

Adverse Events Cofepris PV System : VigiFlow Reporting Process of AEs

Table of Contents

How to Submit a Report on Vigiflow

Content of the Report Moving through the Report Saving the Report Tracking the Report Reporting Timelines References

Global Regulatory Partners Inc. | 2020

Definitions of Pharmacogivilance Terms

The Mexican Regulation NOM-220-SSA1-2016 definespharmacovigilance as;

“Activities related to the detection, evaluation, understandingand prevention of adverse events, suspected adverse reactions,adverse reactions, events allegedly attributable to vaccination orimmunization, or any other safety problem related to the use ofmedicines and vaccines.”


Definitions of Pharmacovigilance Terms

Terms DefinitionsNational Pharmacovigilance Center (CNFV)*

Department responsible to issue the policies and guidelines for the operation of Pharmacovigilance in the national territory.

Adverse event (EA)* any undesirable medical event that may occur with a patient using a clinical investigation drug or approved drug or vaccine but does not necessarily have a causal relationship with it.



Terms DefinitionsState Pharmacovigilance Center (CEFV)*

Unit designated to participate in the execution of Pharmacovigilance activities, in accordance with Standard and applicable regulations and in coordination with the National Pharmacovigilance Center.

Suspected adverse drug reaction (SRAM)*

any unwanted clinical or laboratory manifestation that occurs after the administration of one or more medications.

Pharmacovigilance Unit (UFV)*

entity dedicated to the implementation and management of Pharmacovigilance activities



Terms Definitions

Adverse drug reaction (RAM)*

unwanted response to a drug, in which the causal relationship with it is, at least, reasonably attributable.

Event supposed to be attributable to vaccination or immunization (ESAVI)*

clinical manifestation (s) or medical event that occur after vaccination and are supposed to be attributed to a vaccination or immunization.


Pharmacovigilance Objectives

Detection, identification, quantification, evaluation andprevention of the possible risks derived from the use ofmedicines in humans.

To evaluate the safety of the medicines or vaccines that aremarketed in the country and protect the health of theMexican population, it is necessary to subject them tocontinuous monitoring if they are available.


Pharmacovigilance Regulations in Mexico

This Norm is partially

equivalent to international regulations

ICH- E6

EMA (Good Pharmacovigilance

Practices)

ICH-E2E ICH-E2AICH-E2B Good

pharmacovigilance practices for the Americas (OPS)

Guideline on good pharmacovigilance practices (GPV) Module 1 and annex 1, HMA

NOM-220-SSA1-2016 of Pharmacovigilance

MODIFICATION NOM-220-SSA1-2016 of Pharmacovigilance


Means of Notification of Adverse EventsEntities Reporting Means

National Pharmacovigilance Center (CNFV)

VigiFlow

State Pharmacovigilance Centers (CEFV)

Institutional Pharmacovigilance Coordinating Centers (CICFV)

Institutional Pharmacovigilance Centers (CIFV)

CefV and CICFV-dependent Pharmacovigilance Units (UFVs)

Registration holders or their legal representatives, institutions orestablishments conducting health research, distributors/marketers whoHAVE the ability to carry out the electronic transmission of reportsin E2B-xml format.

Sending E2B- xml files

Registration holders or their legal representatives, institutions orestablishments conducting health research, distributors/marketers who atthe moment DO NOT HAVE the ability to carry out the electronictransmission of reports in E2B-xml format.

e-Reporting

Health Professionals and Patients/Consumers e-Reporting


VigiFlow is a notification management system of SRAM, RAM, EA, ESAVI or any

security problem related to the use of medicines and vaccines that operates online,

It functions as the database of the National Center for Pharmacovigilance, allowing

the collection, and analysis of notifications, allowing the easy transfer of

information to the WORLDWIDE/UMC global database ,

It is compatible with the international standard ICH-E2B (R2 and R3).

VigiFlow allows xml lmport, with the aim of exchanging reports with specific

notifiers, such as the pharmaceutical industry

Cofepris PV System : VigiFlow


Cofepris PV System : VigiFlow


Reporting Process of Adverse Events


How to Submit an SAE Report on Vigiflow• Before manually entering a notification to VigiFlow, you must

ensure that that notification has not been entered previously, either by your own organization or by a 3rd level Pharmacovigilance Unit.

• To do this, you must use specific search filters (on the VigiFlow home screen) to detect duplication, such as:

• Initial• Sex• Date of birth• Suspicious drug• Reaction/Event (MedDRA)


Content of the SAE ReportRequired Fields needed to Submit a Report

Report information

•Initial Receipt Date,• Report Type, •Most Recent Receipt Date

(only when report information is updated)

•Primary Notifier Profession

Patient Info

• Patient's initials or• Sex • Date of birth or• Age at the beginning of

the reaction or Age group• Date of analysis along

with the result of the analysis (section: Analysis and procedures) or• If it is a Father/Mother-

Son report; Gestational age at the beginning of the reaction (if it is a fetus)

• Or Gestational age at exposure (if a fetus)

Medication

• At least one suspicious drug or two Interacting medications

• Name of the medicine (Distinctive or generic name) or

•Name of the drug as reported by the primary notifier (in a free field)

Reaction

• Reaction / event (MedDRA) or

•Reaction/event as reported by the primary notifier (in free field)


Additional fields available on Vigiflow

Narrative cases and additional

information

• Narrative case• notifier comments

Relevant Medical Hx and Previous Relevant

medical treatment

• Clinical hx• Previous medical txt.

Analysis and Procedure

• Name of analysis• Date of analysis• Minimum standard

value• Maximum standard

value• Types of analysis• Results• Notifier commernts

Evaluation

• Methodology used• Source• Relationship

between the medine(s) and the reaction (s)

• Diagnosis• Guest reviews

Content of the SAE Report in Vigiflow


Saving the SAE Report in Vigiflow

• It is important to mention that from the beginning of entering information of a report it is essential to save at all times, through the icon located at the top.

• This action will allow to protect the information at all times in the event of any connection of the Internet or electrical failure that causes the computer to be shut down.

Save button


Saving the SAE Report in Vigiflow

• Once the report is saved for the first time, the system creates this ID, whichconsists of the following 3 elements:• <country code>-<organization name>-<consecutive number> This securityreport ID, you can view it in two sections in the information section of thereport:


Tracking the SAE Report in Vigiflow

• When you need to add additional information (tracking) of a report alreadycaptured in VigiFlow-you do not need to do it through a New Report.

• You should search for the initial report in your main screen report list and openit by pressing the World Unique Identification Number

• The last modified report will be located on the list and click the date onthe left side of the Global Unique Identification Number of the report.


Reporting Timelines

Event Type Reporting timelines

Serious Adverse Events or Suspected Adverse Events 7 days

No Serious Adverse Events 90 days

2 or more serious adverse events occurring at the same place with drugs from the same batch

48 hours

Notification from scientific literature 30 days


References

• NOM-220-SSA1-2016, Installation and operation of pharmacovigilance.https://www.gob.mx/cofepris/acciones-y-programas/farmacovigilancia-73541

• MODIFICATION NOM-220-SSA1-2016, Installation and operation of pharmacovigilance.

http://www.dof.gob.mx/nota_detalle.php?codigo=5601541&fecha=30/09/2020

• Supplement for establishments dedicated to the sale and supply of medicines and other health supplies. Sixth edition. 2018

• https://www.gob.mx/cofepris


https://www.gob.mx/cofepris/acciones-y-programas/farmacovigilancia-73541

http://www.dof.gob.mx/nota_detalle.php?codigo=5601541&fecha=30/09/2020

https://www.gob.mx/cofepris

LET'S TALK NEXT STEPSHOW TO GET IN TOUCH

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