ANVISA – Service Guidance on flows for analysis of drug product application

On September 23, ANVISA published Service Orientation (OS) 90/2020, from the General Management of Medicines and Biological Products (GGMED). This document presents information on the internal flows used to analyze drug products applications that involve the evaluation of several areas of the Agency..

The new Guideline is result of improvements obtained by GGMED after the implementation of OS 59, of 13 March 2019, which established the procedure for simultaneous analysis and the internal flow for concomitant evaluation of documents sent in the application for drug products..

This instruction applies to requests for marketing authorization of new, similar, generic, innovative medicines and biological, specific, herbal, dynamized and radiopharmaceutical products, in addition to linking CADIFA to the respective drug product.

Check below the main information in OS 90/2020:

– To promote the rationalization and agility of the analysis of applications, the evaluation of the marketing authorization will be shared among the areas of GGMED, namely:

  • CBRES (Labeling, Commercial Name and Simplified Registration Coordination) – Documentary evaluation for package leaflet analysis, labeling statements and commercial name;

  • CETER (Coordination of Therapeutic Equivalence) – Documentary evaluation related to studies of relative bioavailability, bioequivalence, pharmacokinetic interaction and biowaiver;

  • COIFA (Pharmaceutical Ingredient Quality Assessment Coordination) – Assessment of DIFA and its changes, for the purposes of granting and reviewing CADIFA;

  • COINC (Incremental Innovation Coordination) – Documentary assessment related to proof of safety and efficacy for marketing authorization of innovative synthetic and semi-synthetic drugs;

  • GMESP (Management of Evaluation of Specific, Notified, Herbal, Dynamized and Medicinal Gases) – Documentary evaluation related to the quality, pharmaceutical technology and proof of safety and efficacy of Herbal, Dynamized, Medicinal, Specific and Notified Gases;

  • GESEF (Safety and Efficacy Assessment Management) – Documentary assessment related to proof of safety and efficacy for the marketing authorization of new synthetic and semi-synthetic drugs, for post-marketing authorization of new and innovative synthetic and semi-synthetic drug products and evaluates of the impurity qualification studies for new, innovative, generic and similar synthetic and semi-synthetic drugs;

  • GPBIO (Management of Evaluation of Biological Products) – Documentary evaluation related to quality, pharmaceutical technology and proof of safety and efficacy of biological products and radiopharmaceuticals;

  • GQMED (Management of Technology Evaluation for Marketing Authorization of Synthetic Drug Products) – Documentary evaluation related to quality and pharmaceutical technology for the marketing authorization of new, generic and similar synthetic and semi-synthetic drug products.

– For there to be a manifestation of the different areas involved in evaluation of drug product, it will be necessary to send a secondary application, linked to the main application, destined to each area and send specific complementary information for each type of analysis. This application must be submited immediately after the main application number has been generated. In case of a CADIFA link, one application will be required for each CADIFA to be associated with the marketing authorization process.

– Each technical area involved in the analysis may manifest itself through the specific application number directed to it, through the issuance of deficiency letter. With the exception of the areas delegated as responsible for the analysis of the main application, which will be responsible for the publication of marketing authorization decision, and which will manifest themselves in the initial application number of request.

– A list of subjects was also made available, which must be submited after the main application, according to each type of regulatory category. Access the complete list through the link:

It is importante to mention that the OS 90/2020 came into force on the date of its publication.

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