INFO KGV | LIFE SCIENCES SEPTEMBER 2019

New regulatory framework for Good Manufacturing Practices for drugs

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Caio Caesar Dib, Kestener Granja and Vieira Advogados

 

On August 22, 2019, the Brazilian Health Surveillance Agency (ANVISA) published the new regulatory framework for Good Manufacturing Practices (GMP) for drugs, which comprises Resolution RDC No. 301/2019 (Portuguese language) and several normative rulings that regulate GMP to guarantee the quality of the drugs manufactured in Brazil.

The new regulatory framework allows Brazil to improve its regulations according to the best international practices and to become more competitive in the global pharmaceutical market. The initiative also qualifies Brazil to become affiliated with the Pharmaceutical Inspection Co-operation Scheme (PIC/s).

It is expected that this harmonisation of Brazil’s GMP regulatory framework with the international standards of PIC/s will enable drug manufacturers located in Brazil to access different markets. It is important to highlight that the increased quality of drugs provided by the new GMP regulatory framework will directly benefit Brazilian consumers.

 

ANVISA PUBLISHES PUBLIC CONSULTATION ON REGISTRATION OF ADVANCED THERAPY PRODUCTS

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On August 28, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation CP No. 706/2019 (Portuguese Language), on the registration of advanced and gene therapy products.

This is the first time that ANVISA has regulated the registration proceedings for advanced and gene therapy products. The main purpose is to provide specific regulations for these products so that Brazilians can access safe treatments for chronic illnesses.

Key points set forth by the proposed regulation include:

• The categorization of advanced therapy products as class I or II, according to their level of manipulation. Gene therapies products, for example, are categorized as class II because the genetic manipulation is extensive.

• Making advanced therapy products which, cumulatively, are (i) non-routinely produced; (ii) produced for a specific patient; (iii) prepared under medical responsibility; and (iv) prepared in accordance with specific quality and safety requirements of the regulation; exempt from registration.

• Subjecting advanced therapy products exempt from registration to the notification or prior authorization regime.

The Public Consultation proposal is based on two regulatory benchmarks: the European standard regarding the technical aspects of the proposal, and the Canadian standard regarding the chosen legal model.

The European standard was chosen due to the clarity and accessibility of its regulatory model, in addition to the fact that its general requirements are in line with those adopted by both the US and Japan.

The deadline for responses to the consultation is 18 October 2019.

 

ANVISA PUBLISHES SERVICE ORIENTATION REGARDING PROCESS OF ANALYZING NEW AND INNOVATIVE SYNTHETIC AND SEMI-SYNTHETIC DRUGS

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Beatriz Liane F. Silva, Kestener Granja and Vieira Advogados

 

On August 19, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Service Orientation (OS) n°70/DIRE2/ANVISA/2019 (Portuguese language), which establishes and optimizes the work process related to analysing the efficacy and safety of new and innovative synthetic and semi-synthetic drugs.

The OS applies to registration and post-registration petitions and determines that data review should follow the guidelines of the Synthetic Drug Evaluation and Effectiveness Review Roadmap.

The document provides the possibility of using the FDA and EMA analysis reports in the process of evaluating efficacy and safety data for the registration of these drugs, which will provide additional input for ANVISA’s decision making process.

The optimization is part of several measures implemented by ANVISA to comply with the registration and post-registration change deadlines for priority and ordinary drugs established by Law No. 13,411/2016 and the deadlines for registration of new rare disease drugs, according to Resolution RDC No. 205/2017.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”