INFO KGV | LIFE SCIENCES JULY 2019
ANVISA APPROVES NEW METHODS FOR RELEASING TESTS OF MEDICAL DEVICES
On June 26, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 291/2019 (Portuguese Language) which approves the adoption of parametric release or the use of biological indicators as part of the monitoring control for medical devices sterilized by ethylene oxide, in place of using traditional sterility tests.
The ethylene oxide sterilization facilities for medical devices were previously regulated by Inter-Ministerial Ordinance No. 482/1999 (Portuguese Language). Companies were required to double check the sterilization of medical devices through a biological indicator as well as a sterility test.
The Resolution applies to manufacturers and sterilization facilities of new medical devices that perform ethylene oxide sterilization.
ANVISA aims to modernize regulations and increase the competitiveness of Brazilian industry both within and outside of Brazilian territory. Countries such as Japan, the US and Mexico, as well as members of the EU already apply parametric release or biological indicators for release of these products.
ANVISA LAUNCHES PUBLIC CONSULTATION TO DISCUSS CRITERIA AND DEADLINES FOR MARKET AUTHORISATION RENEWAL AND NOTIFICATION OF DRUGS
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Caio Caesar Dib, Kestener Granja and Vieira Advogados
On June 26, 2019, the Brazilian Health Surveillance Agency (ANVISA) announced Public Consultation No. 657/2019 (Portuguese Language) to discuss a proposed resolution on criteria and deadlines for Market Authorization (MA) renewal and notification of drugs.
The motivation for such regulatory initiative results from Law No. 13,097/2015 which amended section 12 of Law No. 6,360/1976 to increase the period of the renewal of MAs from 5 to a maximum of 10 years, depending on the product’s nature and public health risk. In this sense, Law No. 13,097/2015 sets forth that the period of renewal must be defined by specific regulation for each category of product under health surveillance.
ANVISA has already defined specific periods of renewal for medical devices. For some other products, such as cosmetics and sanitizers, ANVISA is close to defining specific renewal periods. This new resolution should cover the regularisation of drugs.
ANVISA is accepting public consultation contributions until August 16, 2019.
REGULATORY GUILLOTINE: ANVISA CONTINUES TO ELIMINATE OBSOLETE RULES
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Caio Caesar Dib, Kestener Granja and Vieira Advogados
On June 26, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 292/2019, which revokes several obsolete rules issued by ANVISA and the extinct Health Surveillance Secretariat. The elimination of these rules is part of a strategy of periodical review, the objective of which is to reduce confusion and provide clearer and simpler regulations.
Resolution No. 292/2019 revokes 174 normative acts, of which 166 were issued by ANVISA. The remaining eight were issued by the now defunct Health Surveillance Secretariat.
ANVISA began eliminating obsolete rules and regulations in 2016. Since then, the “Regulatory Guillotine” has revoked 349 ANVISA rules (equivalent to a one-third reduction of ANVISA’s regulations).
ANVISA AMENDS THE DEADLINE FOR PRICE REGISTRATION OF RARE DISEASE DRUGS
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On July 17, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 293/2019 which amends the deadline for price registration of rare disease drugs established by Resolution RDC No. 205/2017 (Portuguese Language). Resolution RDC No. 205/2017 provides for fast track procedures to obtain approval for clinical trials, the Good Manufacturing Practices Certification (GMP) and the registration of new drugs designed for the diagnosis, prevention or treatment of rare diseases.
The new Resolution extends the deadline for the submission of price registration documents before the Brazilian Drug Market Regulation Chamber (CMED). From now on, companies have 30 days from the publication of the rare disease drug Market Authorization (MA) to file the price registration dossier. Previously to this amendment, Resolution RDC No. 205/2017 provided that the price registration must be jointly presented with the drug MA application.
This amendment was necessary due to the conflict between Resolution RDC No. 205/2017 and CMED’s Resolution No. 2/2004 (Portuguese Language): CMED’s Resolution requires the presentation of a previous drug MA application as one of the requirements for price registration.
