RMG
Newsletter – Regulatory Affairs
Register Medical Group
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA
STANDARDIZATION – Learn more about the Unique Identification of Medical Devices Project:
See the updates on the pilot project underway at Anvisa.
Market regulation – Companies must submit a report on the sale of medicines:
Submitting the report is a mandatory condition for adjusting the prices of medicines. Pay attention to the dates!
EUA – FDA
2024 PDA/ FDA Joint Regulatory Conference:
FDA and Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference to emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle.
Click here for more information
FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants:
The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.
MÉXICO – COFEPRIS
Regular obstetric care prevents or detects complications in time that could cause the death of the mother or fetus.
Consumption of folic acid three months before and during the first trimester of pregnancy reduces the risk of birth defects by 90%.
UNITED KINGDOM - MHRA
Medicines and medical devices: Key back-to-school tips
As the new school year looms, the MHRA sets out key advice on children’s medicines and medical devices.
Click here for more information
Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease:
The Medicines and Healthcare products Regulatory Agency (MHRA) has, 22 August 2024, approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
EUROPEAN UNION – EMA
EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II:
The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices.
JAPAN - PMDA
APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2024 / PMDA-ATC Medical Devices Webinar 2024.
Two medical device webinars will be held for foreign regulatory authorities that are involved in the review of medical devices. These webinars will be delivered via live online sessions.
DID YOU KNOW?
The Good Manufacturing Practices Certificate (CBPF) is a document issued by Anvisa attesting that a given establishment complies with Good Manufacturing Practices. The Certificate is issued per manufacturing unit, covering the production lines, pharmaceutical forms, special therapeutic classes and/or risk classes of products for which the company was inspected.
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MERCADOS
- Auditorias e Sistemas de Qualidade
- Consultoria e Assessoria Regulamentar
- Distribuidores de Produtos – Qualificação
- Representação Local
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