Beginning on October 1, 2024, drug companies submitting NDAs, GDAs, and minor variation applications in Singapore must also incorporate GMP Compliance Evidence for their drug substances. There is a grace period until September 30, 2024, but Singapore’s HSA recommends that drug substance... Read More
Despite the ongoing political frictions between the US and China, many Western pharmaceutical companies still rely heavily on Chinese drug companies for the production of APIs, excipients, and finished drug products. To source drug components and drugs from China, meeting Western GMP... Read More
India provides the world with many drug products and drug substances. To ensure high quality, the Union Health Ministry now requires that all state drug authorities gather data on all Indian pharmaceutical companies. The Indian central government wants to collect information on... Read More
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. To register a drug in China, the drug factory must meet China’s GMP standards. China initiated GMP requirements for drugs in 1988 but has revised... Read More
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
Recently, China’s NMPA has started to implement more programs for drug safety. Drug supervision has increased, and the number of crackdowns has jumped dramatically. Last year, there were about 160,000 regulatory investigations of false drug claims, inoperative medical devices, and other problematic... Read More