Regulatory Blog

Bringing innovative medicines to patients requires more than scientific excellence. Pharmaceutical companies must navigate complex regulatory pathways, demonstrate product quality, ensure appropriate labeling, and comply with country-specific requirements before a medicinal product reaches the market. Swissmedic, Switzerland's national authority for therapeutic products, has established several regulatory mechanisms that facilitate patient access to innovative therapies while

Patent information plays a critical role in the regulatory framework for prescription drug approvals in the United States. Accurate submission of patent information helps ensure transparency regarding intellectual property protections associated with approved drug products and supports the operation of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. To assist New Drug Application (NDA) applicants and NDA holders in

Clinical trials are conducted in accordance with approved protocols and regulatory requirements designed to protect participants and ensure the generation of reliable scientific data. However, changes may become necessary during the course of a study due to emerging safety information, operational considerations, scientific developments, or updates to study procedures. The MHRA guidance Clinical Trials for Medicines: Modifying a Clinical Trial Approval provides a framework fo