Brazil Priority Review Update

April 25, 2018 Suzanne Konigsberg

By: Angela McGillivary, Principal Consultant, PAREXEL Consulting

As of December 12, 2017, ANVISA adopted guidance RDC No 204 which Provides for “The framing in the priority category of registration, post-registration and previous consent applications in clinical research of drugs.”

The regulation came into force on the 26th February 2018 and addresses priority review for marketing authorization procedures, post submission changes and clinical trial applications.

RDC No°204 replaces RDC No. 37/2014, which provided for the prioritization of the technical analysis of registration petitions. RDC 37/2014 was repealed by ANVISA on 29th March 2017 so that new laws could be brought into force which regulated the classification of drug applications.

During the period between RDC 37 repeal and when RDC 204 came into force companies had to submit their application for priority review on a case by case basis.

 

What has changed?

The Application for Priority Review is now submitted together with the MAA application, this was previously done after the review of the MAA application.

The application has to meet one or more of the criteria listed in the New Marketing Authorisation and Post Registration checklist available on ANVISA’s website (http://portal.anvisa.gov.br/legislacao#/)

This previously relied on a checklist with a point score system; drugs required a 10 to be eligible for priority review (Normative Document No.3 June 16, 2014 repealed in March 2017).

 

Timelines

Submission Type

Timelines

Priority Review

Typical Non-Priority review

MAA

120 days

12 – 24 months

Post approval Variation

60 days

Up 2 years

Clinical trial Application

45 days

90 days

  • Synthetic drugs
  • Phase III international multicenter trials

 

180 days

  • Biological compounds
  • Phase I/ II trials
  • Local trials

 

 

Once the application for a new MAA has been approved and published in the ANVISA’s official gazette the maximum pricing by the company has to be submitted within 30 days and the drug has to be marketed with 365 days.

PAREXEL Consulting provides dedicated subject-matter expertise that is particularly suited to provide advice to biopharmaceutical companies on the registration, post-registration and previous consent applications in clinical research of drugs in Brazil.

Our Brazil office located in São Paulo has over 100 dedicated staff working in Logistics, Medical Sciences, Clinical operations, Quality and Regulatory Consulting, who have experience with working with ANVISA.

PAREXEL’s subject matter experts can provide advice on which MAAs, post-registration changes and clinical trial would be eligible for priority review and how to coordinate those submissions.

 

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