In 2016, the Brazilian Health Regulatory Agency (ANVISA) became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. This measure favors the growth of the national pharmaceutical market and the harmonization of Brazilian pharma legislation with international practices.


Until 2021, the Agency must adopt the 5 ICH’s guidelines on Clinical Research, Pharmacovigilance, Implementation of the Common Technical Document (CTD) and MeDRA actions.


On August 14, 2019, two Public Consultations were published in the Official Gazette for submission of contributions and will be open until October 21, 2019. Public Consultation 682 proposes the establishment of the Drug Registration Dossier. Public Consultation 683 aims to amend Resolution 200/2017, which regulates the requirements for granting and renewing drug registration with synthetic and semi-synthetic active ingredients and Resolution 73/2016, which regulates the post-registration amendments and deregistration of drugs with synthetic and semi-synthetic active ingredients.


In addition, ANVISA published the Common Technical Document (CTD) Guidelines which provide the format and structure that should be followed for the preparation of drug registration dossiers. This will bring the Agency closer to meeting its 2016 International Conference commitment.


We believe that these changes in the application for drug registration will positively affect the process, both in terms of time and cost, promoting the technological development of pharma industry in Brazil.


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