In our September newsletter, we outlined how crackdowns on corruption are affecting China’s drug market. This crackdown is also affecting China’s medical device business. Last summer, Beijing initiated a crackdown which has led to health facilities being more guarded on device procurement... Read More
As noted in our July newsletter, the Indian authorities required all non-notified Class C and D devices to be registered by October 1. Such devices could include certain X-ray products, ventilators, etc. that have moderate to high risks. However, some medical device... Read More
Today, about 50% of all new drug clinical trials have at least one site in Asia. Despite its small population (about 7.5 million people), Hong Kong is looking to get a piece of the action. Hong Kong has excellent hospitals, doctors, and... Read More
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
On September 18, China’s National Health Commission, released their second list of rare diseases. This list includes 86 rare diseases including Giant Cell arteritis, Gorlin Syndrome, Fragile X Syndrome, etc. No. Chinese Name English Name 1 软骨发育不全 Achondroplasia 2 获得性血友病 Acquired hemophilia... 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
Overview of the MFDS The Ministry of Food and Drug Safety (MFDS), formerly recognized as the Korean FDA, is the regulatory authority responsible for overseeing safety matters related to a wide range of products, including drugs, medical devices, food, functional food, and... Read More
To learn more about how we can help you obtain a DMF in Korea, please contact us. According to the Korean MFDS, all APIs used for medicinal products that require pharmaceutical equivalence should be registered as DMFs in Korea. For the DMF... Read More
As noted in our June Pacific Bridge Medical Newsletter, Japan is planning to implement a two-step registration process for SaMD products in early 2024. If a SaMD product shows strong safety and efficacy, it will get initial approval. Later, if the SaMD... Read More
Many foreign device and drug companies now doing clinical trials, R&D, data collection and other related medical activities in China need to follow China’s HGR regulations. HGR regulations outline what foreign companies need to do when applying for, filing and reporting relevant... Read More