Pharmacovigilance

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In Mexico, Marketing Authorization Holders have the following responsibilities related to pharmacovigilance:

– Inform the competent authorities the identities of the people assigned to pharmacovigilance tasks.

– Have SOPs in place that guarantee:

Reception of any suspicion report from all possible sources.
Registration of any received report, including those of misuse of abuse, coming from healthcare professionals or consumers.
Registration of any information related to the drug when used during pregnancy or lactation and surveil the consequences.
Investigation, particularly on severe and unexpected cases.
Validation of the information through verification of all accessible documentary sources.
Detection of possible duplication of notification of data or adverse reactions.
Storage of all information relevant to collection and documentation of reports. Any information including verbal, must be written, dated and archived.
Upon request from the Pharmacovigilance National Center, provision of estimated frequency of suspicions of adverse reactions and investigation on possible risk factors through intensive pharmacovigilance studies.
Guaranty of the confidentiality of identity of patients and notifiers, verify the security of data storage and transmission, especially electronic data.
SOP and pharmacovigilance information, training and capacitation to the people responsible for this information.

– Notify the Pharmacovigilance National Center of the suspicions of adverse reactions, within the timelines mentioned below.

– Create periodic safety reports for all authorized drug products, following the ICH guidelines, and submit to the Pharmacovigilance National Center:

Every six months during the first two years from marketing authorization.
Annually for the next three years.
After this period, every five years.

– These reports must include:

Brief monograph of the marketed drug product, including generic and comercial names.
Pharmaceutical form.
Period reported and date of the report.
Relevant information on the drug product (technical safety data sheet): total number of reported cases, number of cases for each category of adverse reaction, number and description of severe adverse reactions, new adverse reactions including characteristics, frequency and severity, number of commercialized units, as well as any other information that could help estimate the number of exposed patients.

– Train medical representatives on regulations, methods and objective of pharmacovigilance, as well as on their role in notification collection and information transmission.

Adverse reactions have to be reported through filling of this form, that is also available to complete and submit online here.

The timelines to notify COFEPRIS of adverse reactions are:

– During clinical trials:

Severe or lethal adverse reactions have to be reported immediately. The regulatory authority has to be notified by written communication (also possible through fax or email) as soon as possible within seven days after the sponsor takes notice, and must be followed up with a complete report to be submitted within up to eight additional days.
Mild to moderate adverse reactions, both expected and unexpected, are to be notified in the final summary of the clinical trial that includes all investigation centers.
International safety reports are to be submitted to the Pharmacovigilance National Center every six months, from the approval to the end of the study.

– During the commercialization of the product:

Suspicions of severe or lethal adverse reactions must be reported within seven days from identification; no later than in 15 days if only one case has been identified, immediately when three or more cases have been identified.
Suspicions of mild to moderate adverse reactions, within 30 days from identification.

Last update: October 2013

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