Good pharmacovigilance practices (GVP) are a set of guidelines established by regulatory authorities to ensure the safety of medicinal products. These guidelines provide a comprehensive framework for monitoring, evaluating, and reporting adverse drug reactions (ADRs). However, there are certain situations where exceptions or modifications to GVP may be necessary.

In the ever-evolving world of pharmaceuticals, ensuring patient safety remains a paramount concern. As new drugs emerge and treatment options expand, the importance of pharmacovigilance, the science of monitoring and evaluating drug safety, has never been greater.

Japan is a key market for the pharmaceutical industry, but its drug approval process can be complex and daunting. If you are seeking to introduce a new drug into the Japanese market, you must understand the drug approval process and navigate it effectively.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a historic milestone in the US FDA's oversight of cosmetics. It represents the most significant expansion of the US FDA since the inception of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938.

In the pharmaceutical industry, precision, safety, and compliance are paramount, and hence the role of artwork quality checks holds a critical place. It's not just about aesthetics; it's about ensuring that every piece of artwork adheres to strict Regulatory standards and maintains the integrity of the brand.

The pharmaceutical industry operates in a complex landscape where compliance with stringent regulations is paramount. One area where this is particularly crucial is in the creation and management of Regulatory artwork. Regulatory artwork encompasses everything from packaging and labeling to product inserts and documentation.

Pharmaceutical businesses looking for new business prospects find South Korea to be an attractive market with a fast-increasing pharmaceutical industry. With over nine-hundred (900) new drugs in the pipeline and exports totalling USD 3.1 billion, South Korea provides enormous potential for big pharma manufacturing.

The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.

Japan’s food and dietary supplement market holds great appeal, drawing health-conscious consumers who search for high-quality products. However, you need to navigate a strict Regulatory environment to enter this thriving market.

When it comes to labeling requirements for food and dietary supplements in the European Union (EU), you must pay close attention to detail. The EU has established strict regulations to ensure that consumers receive accurate and transparent information on the products they consume.