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New Efficacy and Safety Analysis Roadmap for Synthetic Drug Registration




What has really changed?

Until recently, ANVISA did not have a standard for describing non-clinical and clinical data on efficacy and safety for drug registration, but since July 2018 we have already published a new script by the agency.

Before the new standard, companies were able to create their own efficacy and safety reporting model, where they described the non-clinical and clinical data available for the pharmaceutical product, freely including the information they deemed relevant. The most common among multinational pharmaceutical companies was to translate the content of the CTD format and present it in the format already organized for other international agencies. The lack of standardization made it difficult to analyze ANVISA and Ad hoc consultants, with a consequent increase in time for the analysis.


But after all, what has changed with the new script published by ANVISA?

The new script is very complete and undoubtedly helps in organizing the information, with a specific numbering for each item of the script, in line with the CTD format, making it easier for the reader to identify the information of interest. There is a clear division of the main contents: analysis of efficacy and safety, non-clinical analysis, biopharmaceutical analysis and clinical pharmacology. And there is also the registration of additional information previously presented on a voluntary basis, such as description of the national therapeutic scenario, post-registration studies undertaken with other regulatory agencies, possibility of abuse and dependence on the drug being evaluated, risk analysis of the benefit of the drug, and ad assessments hoc associated with the registration request.

There is also information on efficacy and safety texts described in the product package insert, now with standardized information, and less space for exploratory data or literal translations of international package inserts.

In the current effectiveness and safety roadmap, in addition to specific numbering for the presentation of each item, it is possible to find where to look for the information to be presented, data that the agency expects to see described in each item and which is the standard or reference guide for the requested information. Although long, the guide is very complete and easy to understand and follow.

The script was based on regulatory standards already in force in the country, but also brought contributions from other relevant agencies on the international stage, such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), in addition to technical documents from ICH (International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use).

As emphasized in the presentation of the script by the GESEF (Efficacy and Safety Assessment Management) team, the proposal aims to add value and standardize the availability of information on the efficacy and safety of pharmaceutical products.


We anticipate that companies will have some difficulty in adapting to the guide, since national companies will need to provide data in greater depth and multinationals will no longer be able to present information received in translated format, without an adaptation of the content. And if you need support, this is an area of ​​great expertise from Inovatie.


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