RMG
Newsletter – Regulatory Affairs
Register Medical Group
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA
Clinical trial of the LepVax vaccine against leprosy authorized:
Approval refers to the phase 1b clinical trial of the candidate vaccine for the prevention or treatment of leprosy, developed in a collaborative effort between national and international institutions.
Chamber for the Regulation of the Medication Market (SCMED)
releases yearbook with data on the national medication market in 2023:
Document provides information on the pharmaceutical industry in 2023, in addition to a statistical annex for detailed and comprehensive analysis of the data.
EUA – FDA
FDA Approves New Treatment for Hemophilia A or B:
Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B.
Click here for more information
Webinar – Abordagem do Ciclo de Vida Total do Produto da FDA para Produtos de Diagnóstico In Vitro (IVDs):
The FDA’s TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by taking into account all available information on safety and effectiveness.
MÉXICO – COFEPRIS
INR alert – osteoporosis affects 10 million people in Mexico:
The most frequent fracture is of the hip; it causes pain, disability and progressive loss of Independence.
UNITED KINGDOM - MHRA
Elafibranor approved to treat adults with a rare liver disease known as primary biliary cholangitis:
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver disease known as primary biliary cholangitis (PBC).
Click here for more information
MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services:
The Medicines and Healthcare products Regulatory Agency (MHRA) launched its ambitious new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products while ensuring delivery for all who need its services – patients and the public, healthcare professionals, researchers and developers.
EUROPEAN UNION – EMA
European medicines agencies network strategy to 2028 – launch of public consultation:
Seizing opportunities in a changing medicines landscape.
Click here for more information
Improving efficiency of approval process for new medicines in the EU:
Measures to optimise use of the EU’s expert resources for faster assessments.
JAPAN - PMDA
Early Consideration:
Consideration and other documents on issues such as the practical application of innovative technologies and the development and evaluation of pharmaceuticals.
DID YOU KNOW?
Low-risk medicine: pharmaceutical product, technically obtained or prepared, with prophylactic, curative or palliative purposes, sold without a prescription, for which there is a low risk that its use or exposure may cause consequences or harm to health when all the characteristics of use and quality established for the product are observed.
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