As part of the improvement in pharmacovigilance, Anvisa announces that the VigiMed system has received new functionalities. The most awaited news is the Medical Dictionary for Regulatory Activities (MedDRA), which has been incorporated into the manual data entry module.
This new measure will allow for a much more agile analysis of the information by the Agency and, in the same way, the decision when it comes to the benefit-risk profile of products. Thus, when companies manually send notifications, their coding will be allowed according to the terms of the aforementioned dictionary, contributing to the receipt of information for analysis by Anvisa technicians with more quality.
However, we need to note that companies will only be able to use this functionality as long as they have the MedDRA License within the validity period, according to the provision of article 35 of the Collegiate Board Resolution (RDC) 406/2020. In the meantime, there is still provisioned a special license shared with official laboratories by Anvisa and small companies. In the current standard, notifications sent electronically by companies, in the ICH E2B standards, already have coding using the MedDRA terms.
Companies that send notifications manually, with the granting of a special license for the foreseen cases, are required to code them with the terms of the MedDRA dictionary on VigiMed from the second half of the year 2022.
Learn about the main changes in the new version of VigiMed:
- The homepage now has quick links and news.
- In manual data entry, there is now functionality for MedDRA encoding, with the possibility to choose the language in the user settings.
- Function that cancels notifications previously sent to Anvisa manually.
- The “Notification Submission Status” page has been improved.
- It is now allowed to download batches of notifications for 7 days after they are sent.
- Relevant medical history with structured information
- Diagnosis of the company on the case.
The tests of the modifications were carried out by a group of pharmaceutical companies from Brazil and other member countries of the International Drug Monitoring Program of the World Health Organization (WHO), from December 2021 to January 2022. The WHO Collaborating Center is evaluating the suggestions forwarded for drug monitoring (Uppsala Monitoring Centre) and will gradually be implemented as the system evolves.
A review of the VigiMed Handbook is also underway with a view to updating these new features. The main changes already incorporated can be consulted here.
Compatibility with the internationally harmonized standard
VigiMed is compatible with the internationally harmonized standard in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH. Anvisa has been a member of this forum since 2018.
To date, more than 60 guides have been developed by the Council, related to aspects of safety, quality, efficacy, and subjects from different disciplines, with emphasis on the MedDRA dictionary of medical terminology. This dictionary is used in VigiMed as a way to standardize the terms that describe the adverse reactions reported in the notifications, as well as for the indications for the use of reported drugs and informed diagnostic tests.
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