As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for…
Finding the right formula for nitrosamine risk mitigation
The pharmaceutical industry is facing many challenges to ensure drug products are free from nitrosamine contaminants and safe for human use. Since the discovery of potentially carcinogenic nitrosamines in some commonly prescribed drug products in 2018, mitigating nitrosamine risk has been a top priority for the pharmaceutical industry and its governing bodies. As such, strict…
Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems
Pharmaceutical regulations in Japan are continuously expanding and updating to improve the safety of pharmaceutical drugs. Throughout history, the detection and understanding of harmful side effects of pharmaceutical drugs have led to new enhancements of regulations to allow regulatory agencies to find adverse events more effectively. In turn, this has led to stricter regulations. Likewise,…