Health Canada : Food and Drugs Act and Regulations
Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. The department exercises this mandate under the authority of the Food…
Pharmaceuticals and Medical Devices Agency (PMDA) : Japan FDA
Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are…
National Medical Products Administration (NMPA) : China FDA
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,…
Therapeutic Goods Administration (TGA) : An Australian Regulatory Authority
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…
Explore the Potential : Medicines and Healthcare products Regulatory Agency (MHRA)
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…
Clinical Trial Regulation: European Medicines Agency
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…
Post Marketing Safety (PMS) Surveillance and Oversight
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…
The Role of the Food Drug Administration (FDA) in Clinical Drug Trials
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…
Reshape Your Medical Device Regulatory Career With British BioMedicine Institute
A medical device is any device intended to be used for medical purposes. What differentiates a medical device from an everyday device is its intended use. Medical devices benefit us…
Researchers Dissect the Coronavirus Genome for Outbreak Answers
The early detection of SARS-CoV genetic material is crucial for improving SARS control, since patients are able to transmit the virus before it can be detected. Thirty thousand base pairs…
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