Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure
Brazil Regulatory Body ANVISA recognizes CEPs:
EDQM website newsroom announced that the Brazilian health authority ANVISA has started to recognize evaluation reports and docum1ents from other authorities as a part of its assessments.
A Common EU Approach to Data Transparency in Medicine Regulation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released a comprehensive update to their guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. This revision reaffirms the commitment of regulatory bodies across the European Economic Area (EEA) to greater transparency, both in response to document access requests and in the proactive release of data following the authorisation of a medicine.
Selection of Reference Medicinal Products (RMPs) for the UK
Starting from 1 January 2025, there will be legislative changes affecting the selection of Reference Medicinal Products (RMPs) used to support abridged applications for UK-wide marketing authorisations.
eCTD IMPLEMENTATION IN TUNISIA
The electronic Common Technical Document (eCTD) system for drug submissions is being implemented by Tunisia’s National Agency for Medicines and Health Products (ANMPS). The regulatory process for pharmaceutical products will be digitized starting in January 2025 with the transition to online submissions (eSubmission).
Overview of MoCRA 2022: Key Provisions and FDA Cosmetic Regulations
A significant increase in the U.S. was achieved through the introduction of several important provisions in the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The FDA is responsible for regulating cosmetics. Some key aspects of MoCRA include: