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
In an effort to reduce the drug lag in Japan, in mid-September, the MHLW said, in general, Phase 1 drug clinical studies are not required before late-stage global studies. This notification will amend the prior notification in 2007 and render invalid a... Read More
Last month, we reported on new consultation services for medical device registration applicants in Malaysia. This month on September 6, Dr. Muhammed Radzi, Malaysia’s Health Ministry Director General announced that Malaysia’s online application system will be upgraded to the MeDC@St 3.0 application... Read More
On August 8, the 9th round of Volume Based Procurement (VBP) was released, and the gathering of volume usage was closed on September 11. The 9th round of VBP included 44 drugs, according to the Chinese health authorities. The 44 drugs include... Read More