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What is the purpose of registration submission guide, based on data from scientific literature?

Last year ANVISA launched the guides for registration submission of synthetic and semi-synthetic drugs for the complete and abbreviated development pathways, and just recently, in July/2021, it has made available for directed consultation the guide for Registration Submission based on data from scientific literature .

What does ANVISA expect from the new submissions with the publication of this new guide?

When starting an incremental innovation project through the abbreviated registration route; that is, when part of the information necessary to prove the safety and efficacy of the drug comes from studies not conducted by the applicant; the first task is to carry out a bibliographic survey. But how to do this in a systematic way, to provide the answers that the company needs and that meets the requirements of ANVISA?

This new ANVISA guide answers this question and guides how companies should carry out a Systematic Review (SR) in order to identify, select, synthesize and critically interpret all relevant evidence of safety and efficacy of the proposed drug; using a rigorous, reliable and reproducible elaboration methodology.

To do so, the company must:

• Describe the search methodology,

•Use an adequate search methodology and carry out an assessment of the quality of the publications presented,

• Seek evidence with structured survey questions,

• Whenever available, include meta-analyses that help to obtain a quantitative overview of a particular research question,

•Assess positive and negative evidence.

Literature and systematic literature review are essential parts of any drug development. It is the central pillar from which the understanding of the product is built, the planning of which data should be generated, the rationale for clinical development, and the design of the bridge study, to cover the gaps in knowledge about the product for the granting of registration and allowing the extrapolation of data from the comparator drug.

In addition, after the completion of the bridge study(s), the bibliographic search must be updated in order to verify if there were relevant publications on the molecule to finalize the safety and efficacy report. The report must contextualize the results obtained in the study as knowledge of the disease, existing treatments, already known results of the molecule, and with the rationale for clinical development. For this important task, ANVISA strongly recommends the adoption of the CTD format, where the Overview and Non-clinical and clinical M4 Abstracts must be presented in Module 2, as well as the clinical module M5, where the complete report of the study conducted must be presented.

It is important to highlight that the guide will not be used only for the preparation of the efficacy and safety report of new and innovative drugs, as from the moment that the CTD is mandatory, even in the submission of generics and similar. In addition to pharmaceutical equivalence studies and bioequivalence, it will be necessary to present module 2 with the non-clinical and clinical overview, built from the systematic bibliographic search and with relevant references presented in modules 4 and 5.

Therefore, knowledge of how to carry out a good literature review, and how to prepare the safety and efficacy report, becomes essential for companies in the pharmaceutical sector.

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