Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market is the Periodic Safety Update Report (PSUR).
Artwork Divisions in Pharmaceutical Packaging
The pharmaceutical packaging industry is complex, highly regulated, and essential to ensuring the safety and efficacy of products. Artwork divisions are a fundamental part of this process, providing the expertise needed to create packaging that is both compliant and effective. From navigating intricate regulatory requirements to understanding the nuances of various pharmaceutical products, artwork divisions contribute significantly to the success of a product in the marketplace.
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.