Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. China GMP requirements are important for medical device registration in China. Key areas for China GMP requirements cover device manufacturing, product labeling, R&D design, warehousing,... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. When a foreign drug company wants to register its drug in Japan, one of the most important steps is Japan GMP requirements. These GMP... Read More
Contact us today for a free consultation with a Taiwan regulatory affairs consultant to discuss your specific needs. History and Overview The Taiwan Food and Drug Administration (TFDA) was established on January 1, 2010. The establishment of the TFDA followed the enactment... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. History and overview Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for supervising Japan’s medical regulatory procedures, conducting reviews of pharmaceutical and medical... Read More
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. History and overview The NMPA, formerly known as the China Food and Drug Administration (CFDA), traces its origins back to the earlier State Food and... Read More
To learn more about how PBM can help you register your drug products in Singapore, please contact us. Introduction An island nation of 5.4 million people, Singapore is considered one of the most developed pharmaceutical hubs in Asia. With its current market size... Read More
Please feel free to contact us to obtain more information about Japan DMF. Drug component manufacturers of APIs, excipients, and drug packaging materials who want to protect their intellectual property and manufacturing processes may want to pursue a Japanese Drug Master File... Read More
On July 10, the Japanese MHLW outlined a plan to increase the number of products allowed to apply for Orphan Drug Designation (ODD) and permit this designation earlier in the drug development process. Currently, Japan only accepts orphan drugs that are for... Read More
Device classification in China can sometimes be a tricky issue. If the classification is unclear, device companies can submit an online application to determine the classification. After the online submission, the applicant needs to submit hard copy documents and gain acceptance and... Read More
While much of the Western world has initiated regulations and reimbursement for SaMD products, Japan is still grappling with this product category. The number of SaMD product approvals in Japan dwarfs the number of approvals in the West. As Japan gets more... Read More