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
On May 20, known as International Clinical Trials Day in China, a number of Chinese hospitals and related groups provided an in-depth educational session to help enlighten Chinese patients about participating in local clinical trials. Over 30,000 Chinese attended these informational sessions,... Read More
Market Authorizations (MAs) for drugs in Thailand before 2019 never expired. With the implementation of the 2019 Thai Drug Act, drug MAs were only good for 7 years but could be renewed. Now, the Thai Drug Act has set out a detailed... Read More
India provides the world with many drug products and drug substances. To ensure high quality, the Union Health Ministry now requires that all state drug authorities gather data on all Indian pharmaceutical companies. The Indian central government wants to collect information on... Read More
Please click here to access the presentation slides: Japan Pharmaceutical Registration Update 2023 Read More
Like other drug markets, downward price revisions in Japan are common. In an effort to boost drug prices, Japan has a program called the Price Maintenance Plan (PMP). Under the PMP plan, the MHLW allows an additional premium to specific drug prices.... Read More
On August 17, the NMPA announced that its classification catalog would be adjusted given the influx of new innovative devices. Fifty-eight product categories have been updated. However, only 4 product categories have been changed from Class 1 to Class 2 or from... Read More
In the past, it was not possible to meet Malaysia MDA officers face-to-face. They were always resource-constrained and did not have time. However, on August 2, Malaysia’s MDA announced new consulting services for device manufacturers seeking medical device registration approval in Malaysia.... Read More