As noted in our previous monthly new briefs, China has initiated various VBP, DRG, and DIP pricing plans to reduce prices for drugs and devices. China’s VBP program looks to reduce pricing by awarding large volume sales to tender winners. In early... Read More
In late December, the MHLW announced an update to its Sakigake fast-track registration system. In the past, for an innovative drug to be eligible for the Sakigake system, it had to be either filed in Japan at the same time it was... Read More
Starting January 1, 2024, the Chinese NRDL will add 124 new drugs including 15 drugs for rare diseases, 17 anti-virals including anti-COVID products, 15 drugs for chronic diseases like diabetes, and 23 cancer products. To be eligible to enter the NRDL, almost... Read More
As mentioned in our September newsletter, Laos’ Food and Drug Department (FDD) put into practice its Registration and Notification of Medical Devices (Decision 1470) in October 2023. Laos follows the ASEAN harmonized risk classification list for medical devices. According to their new... Read More
In the past, drug registration in Hong Kong required that a foreign drug had approval in 2 reference countries. Late last year, the Hong Kong Department of Health announced the “1+” mechanism which now allows drug approval if the drug has been... Read More
Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements. China removes tariffs on 62... Read More
Late last year, Vietnam’s MoH announced Circular 23/2023/TT-BYT which updated the 2018 drug labeling requirements. The new drug labeling law will take effect on January 15, 2024. However, there will be a transition period until January 1, 2025. Therefore, drugs imported or... Read More
Successful clinical trials in Japan are key to drug registration. There have been several regulations and guidelines for Japanese clinical trials over the years. Japan’s clinical trial regulations are regulated by the MHLW and outlined in the PMD Act as well as... Read More
With political tensions in China growing and more companies trying to reduce costs, more and more Western drug and device companies will look to do clinical studies in India. While India accounts for close to 18% of the world’s population, its share... Read More
This article was originally published on MedTech Intelligence. Companion diagnostics (CDx) plays a pivotal role in personalized medicine—one of the fastest-growing areas of medicine. Regulation of CDx is fairly well established in Western countries, but the East is not far behind. Here... Read More