Register Medical Group

Newsletter – Regulatory Affairs
EVERY 1ST AND 3RD THURSDAYS OF THE MONTH
BRAZIL – ANVISA

Ombudsman publishes the 2023 Annual Management Report
The document presents an overview of users’ perception of the public services provided by the Agency.

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Insulin Glargine is once again manufactured in Brazil
Anvisa approved changes that allow manufacturing stages of Biomm company’s product in Brazil.

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EUA – FDA

WORKSHOP | MIXED MAY 13, 2024
The FDA’s Center for Drug Evaluation and Research, NIH’s National Center for Advancing Translational Sciences, and the Reagan-Udall Foundation will host a public workshop titled Natural History Studies and Registries in the Development of Rare Disease Treatments.

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Mammography Quality Standards Act and Program
On March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented by mammography facilities within 18 months after publication in the Federal Register.

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MÉXICO – COFEPRIS

It is estimated that 1% of the world’s population suffers from autism spectrum disorder.
It is important to monitor the socio-emotional development of infants during the first thousand days of life.

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UNITED KINGDOM - MHRA

Case study – Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.

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MHRA warns of unsafe counterfeit anti-choking devices Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK.
The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is a counterfeit.

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EUROPEAN UNION – EMA

Regulatory information – adjusted fees for applications to EMA from 1 April 2024
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, came into effect on 1 April 2024.

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Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU:
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU).

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JAPAN - PMDA

PMDA-ATC Pharmaceuticals Review Seminar 2024 for PPWG member states:
The Pharmaceuticals and Medical Devices Agency (PMDA) are pleased to announce the “PMDA-ATC Pharmaceuticals Review Seminar 2024 for PPWG member states” for reviewers of ASEAN PPWG member states.

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DID YOU KNOW?

Anvisa provides an AFE Certificate for use nationwide, and an AFE Certificate when dealing with export-oriented activities.
In the first case, it will be necessary to pay the Health Surveillance Inspection Fee (TFVS). The second case is exempt from TFVS.

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MERCADOS
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  • Consultoria e Assessoria Regulamentar
  • Distribuidores de Produtos – Qualificação
  • Representação Local
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