RMG
Newsletter – Regulatory Affairs
Register Medical Group
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA
VIRTUAL SEMINAR
Participate in the webinar on changes in administrative treatment for imports:
Virtual meeting to guide importers will be on 7/22, at 3pm.
Anvisa provides a tool for updating provisional drug prices:
Updating the system will allow better management of processes involving medicines pending information for definitive pricing.
EUA – FDA
FDA Updates Guidance to Further Empower Companies to Address the Spread of Misinformation:
The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.
Click here for more information
WEBCAST | VIRTUAL – August 22, 2024 – 1:00 PM – 2:30 PM:
Webinar – In Vitro Diagnostic Products (IVDs) – MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements
MÉXICO – COFEPRIS
Cancer Announcements:
Self-care, maintaining an adequate weight and avoiding alcohol and tobacco consumption are protective factors for some types of cancer.
UNITED KINGDOM - MHRA
Ocrelizumab approved as an injection to treat multiple sclerosis in adults:
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults.
Click here for more information
UKHSA encourages timely vaccination as whooping cough cases rise:
New data published today by the UK Health Security Agency (UKHSA) shows cases of whooping cough continue to increase with 2,591 cases confirmed in May.
EUROPEAN UNION – EMA
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna:
Opinion follows review of additional data and advice from group of experts.
JAPAN - PMDA
USP-MHLW/PMDA Joint Worksho – initiatives related to pharmaceutical:
The purpose of the workshop is to discuss the latest efforts of USP and MHLW/PMDA/JP to ensure pharmaceutical quality in Japan and the East Asia, as well as the prospects for the pharmaceutical industry, government agencies, and pharmacopeias.
DID YOU KNOW?
The importer and/or holder of product regularization is responsible for complying with and observing regulatory and legal standards, measures, formalities and requirements for the administrative import process, in all its stages, from shipment abroad to sanitary release at the National territory.
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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