INFO KGV | LIFE SCIENCES AUGUST 2019
ANVISA publishes Service Guidance in order to expedite the assessment of Drug Clinical Development Dossier
On August 1st, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Service Guidance No. 69/2019 (Portuguese Language) which aims to expedite the assessment of the Drug Clinical Development Dossier (DCDD). The DCDD is required for the clinical trials authorisation procedure regulated by Resolution RDC No. 9/2015 (Portuguese Language).
The Service Guidance allows ANVISA to accept the previous assessment carried out by founding member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (that is, the US, EU and Japan) and is applied to cases that fulfill the following conditions:
- The DCDD must comprises at least one Phase III clinical trial, refer to experimental drugs, contain all manufacturing steps, (except labeling) and have started the clinical trial in at least one of the founding member countries of ICH.
- The experimental drug must be identical, without any alteration in its quality aspects to the one developed in the clinical trial conducted in at least one of the founding member countries of ICH.
- The manufacture of the experimental drug must comply with ICH guidelines concerning the phase of clinical development.
ANVISA expects to achieve a more attractive regulatory background for clinical trials in Brazil.
ANVISA CONDUCTS PUBLIC HEARING ON REGULATING CANNABIS FOR MEDICINAL AND SCIENTIFIC PURPOSES
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Caio Caesar Dib, Kestener Granja and Vieira Advogados
On July 31, 2019, the Brazilian Health Surveillance Agency (ANVISA) held Public Hearing No. 7/2019 (Portuguese Language) to discuss the intended regulation of medicinal cannabis. The Public Hearing was divided in two parts: Public Consultation No. 655/2019 (Portuguese Language) which provides the technical rules for the cultivation of cannabis for medicinal purposes and Public Consultation No. 654/2019 (Portuguese Language) which provides specific requirements for registering and monitoring cannabis-derived drugs.
The final results of the Public Hearing published by ANVISA demonstrate that 67.8% of contributors considered that ANVISA’s proposals had only positive impacts. Another 13.4% participants felt that the proposals had positive and negative impacts and 2.3% considered that the proposals had only negative impacts.
Having now gathered the information at the Public Hearing, ANVISA will assess it and will both respond to contributors and proceed with the evaluation of the regulatory proposals.
ANVISA OPENS PUBLIC CONSULTATIONS ON POST-REGISTRATION ALTERATIONS OF BIOLOGICAL DRUGS
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On August 14, the Brazilian Health Surveillance Agency (ANVISA) commenced two public consultations in order to review Resolution RDC No 49/2011, which establishes the post-registration alterations regarding biological drugs:
Public Consultation No. 686/2019 provides a proposal for a Normative Ruling that aims to regulate:
- The classification of the post-registration alterations.
- The documents required to present a petition for a post-registration alteration, renewal, or cancellation of biological products registration.
Public Consultation No. 687/2019 proposes to revoke Resolution RDC No. 49/2011 with a Resolution RDC that updates the procedure, categorisation, conditions and documents required for post-registration alterations to biological drugs. One of the key points of the proposed Resolution RDC is the requirement for Good Manufacturing Practices Certification (GMP) only in case of quality alterations. The current Resolution RDC No. 49/2011 requires the presentation of GMP Certification for all types of post-registration alterations.
Contribution forms to Public Consultation No. 686/2019 and Public Consultation No. 687/2019 will be open until October 18, 2019.
ANVISA TO POTENTIALLY CONSULT 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 20, 2019, the Board of Directors of the Brazilian Health Surveillance Agency (ANVISA) discussed the possibility of commencing a public consultation on the registration of advanced and gene therapy products according to item 2.3.1. of Meeting Docket No. 19/2019 (Portuguese Language). The Public Consultation shall present a draft of a Resolution RDC regarding the procedure to register advanced and gene therapy products.
Advanced therapy products are biological drugs constituted through human cells and tissues, which undergo manufacturing processes to instill therapeutic, prophylactic or diagnostic effects. These products have significant promise in the treatment of chronic illness, such as cancer and hemophilia.
The proposal to commence the public consultation represents great progress in developing the Brazilian regulatory framework for advanced therapies, which, currently, is composed of two Resolutions RDCs:
According to ANVISA, the publication of the Resolution RDC regarding the procedure to register advanced therapy products is a priority for 2019.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
