Over the last 20 years, China’s drug business has seen tremendous growth. Western drug companies have heavily relied on China for drug products, drug substances, R&D, clinical trials, etc. However, now with increased geo-political friction between the US and China, more Western... 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
1. Overview The Philippines Food and Drug Administration operates as a regulatory body within the Filipino government’s Department of Health. Its primary responsibility is to ensure the safety, efficacy, and quality of various health products including, drugs, medical devices, food, cosmetics, biologicals,... Read More
As reported over the last 6 months, Japan’s MHLW is initiating plans to reduce its drug lag and drug loss problems. Accordingly, the MHLW has increased its budget to expedite drug approvals in 2024 and strengthened its price maintenance plan. In addition,... Read More
Meeting Japanese drug GMP requirements is a key factor for drug registration in Japan. In the past, pharmaceutical inspections were done by prefectural governments at generic and other drug factories, and the PMDA did inspections at factories with high-risk drug products, like... Read More
As mentioned in our July Pacific Bridge Newsletter, Korea plans to increase drug reimbursement for innovative, cancer and rare disease drugs. This reimbursement increase has been confirmed in the recently released Seoul National University R&DB Research Foundation report. In addition to better... Read More