13 de junho de 2019

BRAZIL NEWS: Anvisa publishes Guide on Topical & Transdermal Products


From: www.anvisa.gov.br

The first version published will remain open to contributions until 29 May, 2020.

Anvisa issued this week a Guide on Quality Requirements for Topical and Transdermal Products Registration (Guia nº 20/2019 - GUIA SOBRE REQUISITOS DE QUALIDADE PARA O REGISTRO DE PRODUTOS TÓPICOS E TRANSDÉRMICOS). The publication's main objectives are to provide greater regulatory transparency to the registration of these drugs and to harmonize Anvisa's regulatory requirements with international practices. 

In addition, it intends to provide guidance and recommendations to the pharmaceutical industry on quality requirements for the registration of new, generic and similar topical and transdermal drugs.

The guide was prepared based on the national regulation of drug quality demonstration, as well as official compendia and guides issued by international authorities and the technical and scientific experience accumulated by Anvisa on the subject.

Currently, safety, efficacy and quality requirements necessary for the registration of synthetic medicines such as those covered by the guide are regulated by the Resolution of the Collegiate Board (RDC) 200/2017. However, the peculiarity of pharmaceutical technology of topical and transdermal products justifies the needed on developing a specific guide on the subject.

Thus, the new publication exposes the Agency's position on the tests that can be applied in the development, quality control, stability study and pharmaceutical equivalence of these products, which can be used as a reference by the pharmaceutical industries.

Even effective May 29, the guide is open for contributions until May 29, 2020. 

Contributions must be submitted by electronic form (available only on Portuguese).