Korea is currently the 10th largest drug market in the world. While in the past, Korean drug companies mostly made generic drugs, today, they are making new chemical and biological products. Korean drug companies and foreign drug companies looking to sell their... Read More
1. Overview Established in 1945, the Ministry of Health (MoH) in Vietnam is a government agency tasked with overseeing and managing various aspects of public health and healthcare products. This includes pharmaceuticals, medical devices, preventive medicine, medical care and treatment, rehabilitation, traditional... Read More
On September 18, China’s National Health Commission (NHC) released its second list of rare diseases. This list includes 86 rare diseases including Giant Cell arteritis, Gorlin Syndrome, Fragile X Syndrome, etc. For a complete list, please click here. It is estimated that... Read More
In October, Singapore plans on starting a 90-day trial to determine the cybersecurity risk of medical devices. This is a joint effort between Singapore’s MOH, the Cyber Security Agency and the National Health Technology Agency (Synapxe). The fear is that some devices... Read More
While the US and EU follow ICH’s Q12 guidelines for post-marketing drug approval changes, Japan does not. Post-marketing changes in Japan require applications for partial change approval and minor change notifications for low and high-risk changes. In Japan, these take a lot... Read More
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