ANVISA PUBLISHES PUBLIC CONSULTATION ON CLINICAL TRIALS INVOLVING PRODUCTS FROM ADVANCED RESEARCH THERAPY

On 9 November 2017, the Brazilian Health Surveillance Agency (ANVISA) published a public consultation on the procedures and regulatory requirements to perform clinical trials involving products from advanced research therapy within the Brazilian territory.

Under the current regulation, clinical trials involving products from advanced research therapy follow the same regulatory path as those concerning products developed with human cells, tissues and organs that are not for advanced research therapy purposes. The problem is that manipulating products from advanced research therapy involves more complex techniques in comparison, such as placing cells in non-traditional environments, changing cells’ biological characteristics to make them work in distinct functions in the body and recombining genes for therapeutic, prophylactic or diagnostic effects.

Along with the complex techniques of manufacturing, difficult challenges regarding the control of the quality, safety and effectiveness of such advanced products, which are not covered by the current regulation, also arise. The public consultation proposes a resolution (resolução da diretoria colegiada) that aims to: (i) bring safer and more adequate rules for the study and development of such products; and (ii) follow the steps of the major regulatory agencies worldwide.

Responses to the consultation may be submitted from 16 November to 15 December 2017 through ANVISA’s website.

Source: ANVISA: Motion for a resolution of the Collegiate Board, which provides for procedures and regulatory requirements for conduction of clinical trials with Products of Advanced Research Therapies that can be registered in Brazil (Portuguese language); and ANVISA: Public Consultation No. 416, 8 November 2017  (Portuguese language).

ANVISA publishes new public consultation on importation of non-registered products

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and César Santos Borlina, Kestener Granja e Vieira Advogados

On 19 October 2017, the Brazilian Health Surveillance Agency (ANVISA) published a public consultation regarding the criteria and procedures for the import of non-registered products subject to health surveillance when exclusively intended for exceptional cases within programmes of the Ministry of Health (MoH) in the Brazilian Public Health System (SUS).

The public consultation proposes a resolution (resolução da diretoria colegiada) that aims to provide rules that allow ANVISA to authorise the importation of products without registration in Brazil that are: (i) purchased through multilateral organisations; and (ii) intended to supply specific programmes of the MoH.

This issue was previously discussed under a public consultation that was published in April 2017 (see Legal update, ANVISA publishes public consultation to regulate the import of non-registered products). After receiving numerous contributions, ANVISA decided to reformulate the proposed resolution for solicit comments from the regulated sector.

In comparison to the previous draft, the new proposition offers more detailed provisions on the situations in which the importation of non-registered products is allowed. The prior draft was not clear on whether non-registered products could only be imported from multilateral organisations (such as the Pan American Health Organization) or whether they could be imported directly from the manufacturer in some cases. The new resolution provides clarification, proposing that in emergency cases, as defined by Decree No. 7,616/2011 or by international health regulations, the products could be purchased from players other than multilateral organisations.

The new resolution also reduces, from 30 to 10 days, the term in which ANVISA must assess an application for exceptional import of non-registered products.

Contributions to the public consultation may be submitted until 24 November 2017 through ANVISA’s website.

Source: ANVISA: Public Consultation No. 414/2017, 18 October 2017. (Portuguese Language)

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