The pharmaceutical industry is one of the most complex and regulated sectors in the world. However, with the rise of artificial intelligence (AI), there’s an incredible opportunity to accelerate processes, lower costs, and ultimately improve patient outcomes. AI is transforming various aspects of the pharmaceutical sector, from drug discovery to clinical trials, and even personalized medicine. Here’s a breakdown of how AI will make a major impact on pharma.
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.
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.
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.