The Thai Food and Drug Administration (FDA) has announced new regulatory frameworks designed to elevate the quality of medical devices in Thailand. As part of this initiative, two important notifications have been issued: the Good Manufacturing Practice (GMP) and the Good Importing... Read More
While Indian drug prices had grown considerably in 2023 (up 12%), in 2022 (up almost 11%) and in 2021 (up almost 11%), drug prices remained flat in 2024 with an increase of only 0.0005%. This tiny price increase is for the National... Read More
Registering drugs in Japan can be a very tedious process, but the benefits can also be quite large. Japan has a large aging population that heavily relies on new and innovative drugs. Besides a dossier product submission, drug companies need to obtain... Read More
In recent years, Thailand, a Southeast Asian country with 70 million people, has been consistent in its commitment to improving the regulation of pharmaceuticals, ensuring the safety, efficacy, and accessibility of drugs in the market. Two significant developments include the initiation of... Read More
Singapore is an important drug market in Asia. Not because of the market size which is rather small, but because it is the second best overall healthcare market in Asia, after Japan. Getting drug approval and being successful in the Singapore market... Read More
In an effort to streamline and modernize its medical device regulations, Vietnam has recently implemented significant updates, aiming to enhance efficiency while ensuring the safety and efficacy of medical devices. Two key developments, Circular 10/2023/TT-BY and Decree #07 mark, substantial shifts in... Read More
Singapore has the second best healthcare system in Asia after Japan. Thus, as a healthcare leader, Singapore constantly updates its regulations to adapt to new technologies. Singapore is working towards enhancing the cybersecurity and regulatory compliance of medical devices. With the increasing... Read More
Chinese patients want more drugs to treat their diseases. With over 1.4 billion Chinese people and with more than 350 million people in China’s middle class, there is enough disposable money to pay for them. To get more drugs approved in China,... Read More
The Japanese government is very aware that many drugs approved in the West are not approved in Japan. The issue of drug lag in Japan is significant as it deprives Japanese citizens of access to the same cutting-edge pharmaceuticals that benefit people elsewhere in... Read More
Japan’s medical device market is the third largest medical device market in the world, after the US and China. While it is a highly competitive market, unique products with good value propositions can be very successful there. While in the past Japan... Read More