RMG
Newsletter – Regulatory Affairs
Register Medical Group
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA
International cooperation – Anvisa and FDA sign Confidentiality Agreement:
The document was signed to facilitate the exchange of information on regulated drugs in pre-market and post-market phases.
Anvisa publishes English version of IN 289/2024 and questions and answers on regulatory confidence:
Normative Instruction 289/2024 establishes procedures to optimize the registration and post-registration analysis of medicines, biological products, vaccines and letters of adequacy of active pharmaceutical ingredient dossier (Cadifa).
EUA – FDA
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia:
It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
Click here for more information
Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub:
The meeting will bring together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the recently announced Rare Disease Innovation Hub can best engage with members of the rare disease community and prioritize its work.
MÉXICO – COFEPRIS
Stress, anxiety and depression promote the development of irritable bowel syndrome:
In most cases, stress, anxiety and depression are factors that promote the development of the symptoms of this pathology.
UNITED KINGDOM - MHRA
MHRA approves first medicine for rare immune disease APDS:
The Medicines and Healthcare products Regulatory Agency (MHRA) has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years-old and older who weigh 45kg or more.
Click here for more information
MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox:
The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
EUROPEAN UNION – EMA
EMA recommends suspension of sickle cell disease medicine Oxbryta:
Measure taken as precaution while review of emerging data is ongoing.
Click here for more information
Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system:
EudraVigilance is the EU’s system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
JAPAN - PMDA
International Activities:
The PMDA-ATC offers you videos on introduction to the main services of PMDA to promote international regulatory harmonization.
DID YOU KNOW?
In vitro diagnostic products are reagents, calibrators, standards, controls, sample collectors, materials and instruments, used individually or in combination, with the intended use determined by the manufacturer, for in vitro analysis of samples derived from the human body, exclusively or primarily to provide information for diagnostic, monitoring, screening purposes or to determine compatibility with potential recipients of blood, tissues and organs.
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