As per ResolutionNo466 and OSNo001/2013, Brazil has a centralized registration process for ethics committee (ECs) and requires institutional level EC approval for each trial site. The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) serves as the central body that reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body for the Ministry of Health (MOH).
CEICs meetings may only occur when the majority of its members are present. If a quorum is not reached at the 1st call for the meeting, a new one must be called and then a quorum is constituted as long as one third of the voting members are present. Continue reading “July 2018: Portugal Regulatory Update”
The β-Site Amyloid Precursor Protein Cleaving Enzyme 1 (BACE1) is an enzyme required for the production of β-amyloid (Aβ) in one of the main signalling pathways in Alzheimer’s disease (AD). Excessive production of this leads to Aβ plaque formation, a pathological hallmark of AD. As such, many institutes have been experimenting with blocking this production by producing BACE1 inhibitors. Continue reading “Why are BACE inhibitors failing clinical trials? (EPR)”
HBD has a workgroup focused on moving Japanese and U.S. clinical study sponsors and regulatory agencies toward the use of a single global clinical trial protocol for evaluating cardiovascular devices rather than parallel country-specific protocols. Continue reading “June 2018: Japan Regulatory Updates”
As stated in ResolutionNo9 and ResolutionNo222, applicants are responsible for paying a Proof of Deposit Health Surveillance Rate (TFVS) fee to submit a clinical trial application to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA).
For obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Portugal, namely for clinical trials with medicines or studies with intervention of medical devices, regardless of whether this is for a single site or multiple sites, the sponsor have to request an opinion from the National Research Ethics Committee – CEIC – according to the guideline available on the website http://www.ceic.pt. For the other studies, the request has to be made to local health institution ethics committees.
Researchers in Japan today announced the launch of a clinical trial to treat Parkinson’s disease with neurological material derived from induced pluripotent stem (iPS) cells, mature cells chemically manipulated to return to an early stage of development from which they can theoretically differentiate into any of the body’s specialized cells.
In accordance with the LawNo9.782, ResolutionNo9, and Ord650/2014, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is responsible for reviewing and approving clinical trial applications for registered and unregistered drugs. Continue reading “May 2018: Brazil Regulatory Update”
The Law 46/2004 of 19 August 2004 which incorporates the principles of the Clinical Trials Directive 2001/20/EC and creates the “Comissão de Ética para a Investigação Clínica” (National Ethics Committee for Clinical Research – CEIC) was repealed by a new law (Law 21/2014 of April 16) Continue reading “May 2018: Portugal Regulatory Updates”