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Biosimilar regulations, based on the European Union’s existing processes, were issued by Japan’s regulatory body for the approval of medicines, the Ministry for Health Labour and Welfare (MHLW), in March 2009 . The MHLW’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars.
Original Article: Regulation of biosimilars in JapanNEXT ARTICLE
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...
Antibodies Antisense Assays Biochips Bioinformatics Biological Therapy Biomarkers Biomaterials Bioscience Cell Culture Cloning Cytokine Diagnostics Dna Extraction Dna Sequencing Dna Transform...