RMG
Newsletter – Regulatory Affairs
Register Medical Group
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA
Anvisa launches its new legislation portal, AnvisaLegis:
New portal brings improvements to access the entire set of Anvisa’s standards and regulatory processes..
Anvisa approves new framework for clinical research rules in the country:
Measure modernizes rules and should encourage the development of clinical research in the country.
Anvisa approves registration of first gene therapy product for Duchenne Muscular Dystrophy (DMD):
Elevidys® has been approved in Brazil to treat children aged 4 to 7 years.
EUA – FDA
USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers.
Click here for more information
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
MÉXICO – COFEPRIS
Cofepris authorizes innovative treatment for Alzheimer’s patients:
COFEPRIS reaffirms its commitment to authorizing treatments that contribute to providing adequate care and improving the quality of life of patients.
Click here for more information
Platform for irregular medicine distributors:
Consult the list of irregular distributors of medicines and the Alta Directiva Sanitaria to serve as a distributor.
UNITED KINGDOM - MHRA
MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach:
The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively.
Click here for more information
The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025:
With industry already showing a very high level of readiness, the MHRA is reminding remaining marketing authorisation holders to ensure they are prepared for the new packaging and labelling measures.
EUROPEAN UNION – EMA
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
JAPAN - PMDA
PMDA Medical Safety Information: Drug Confusion Due to Name Similarities (No. 51) Revised (No. 69) Published.
DID YOU KNOW?
The clinical investigation is any systematic investigation or study in one or more human subjects, conducted to evaluate the safety, clinical performance and/or efficacy of a medical device. For the purposes of this regulation, this term is synonymous with “clinical trial” or “clinical research”.
MERCADOS
Arábia Saudita, Argentina, Austrália, Brasil, Canadá, China, Colômbia, Costa Rica, Egito, Estados Unidos, Europa, Hong Kong, Índia, Israel, Malásia, México, Nova Zelândia, Rússia, Singapura, Taiwan
MERCADOS
- Auditorias e Sistemas de Qualidade
- Consultoria e Assessoria Regulamentar
- Distribuidores de Produtos – Qualificação
- Representação Local
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