In the U.S., the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices,
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. Post Market
The implementation of the new European Union (EU) Clinical Trial Regulation will provide a unified portal and database for trial sponsors and regulatory agencies across the EU Member States, promising to bring
The medicines regulatory environment is evolving rapidly in response to the changing environment. The role of the MHRA is to regulate medicines, medical devices and blood components for transfusion in the UK.
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. It carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an
China’s State Food and Drug Administration (CFDA China, renamed to National Medical Products Administration or NMPA China in 2018) is Chinese government’s administrative body responsible for regulating pharmaceuticals, medical devices, and