WHODrug is a drug product dictionary, used to identify drug product’s names and review drug product’s information, including drug substances (active ingredients), anatomical and therapeutic product classifications, in nearly 150 countries. In this dictionary you can find drug products, vaccines, herbal products, biological products, etc.

It is also a source or tool used to interpret and evaluate drug product-related safety issues.

Cofepris announced on December 22nd 2022 the implementation of WHODrug for various pharmacovigilance activities, such as, reporting of suspected adverse reactions to drug products on the VigiFlow and e-Reporting platforms for the industry, among others. Its use is mandatory as of January 1st, 2024.

Cofepris gave one year (all of 2023) for the pharmaceutical industry, through its pharmacovigilance units, to acquire the license to use WHODrug and thus be able to comply and carry out pharmacovigilance activities as requested by the Authority.

It is expected that in the month of October, the National Pharmacovigilance Center (CNF) will hold a training session on the use of WHODrug, for which it will invite the heads of the Pharmacovigilance units to attend.

With the use of WHODrug, progress is made in the implementation of the ICH guidelines, since it corresponds to the M5 guide. It is very good that Cofepris continues to advance in the implementation of the ICH guidelines, since this will allow it to continue being a member, thus, the population will have greater access to various medicines.