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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 Malay 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 registration approval in Malaysia. Two types... Read More

China’s Center for Drug Evaluation (CDE) issued new guidelines in late July supporting the use of DCT via telemedicine to allow clinical trials to be done remotely. The DCT guidelines may be implemented as long as investigators and sponsors agree and the... Read More

The MHLW’s proposed 2024 budget will increase about 12%. Part of this increase will be used to set up a new regulatory consultation group which will focus on expediting pediatric and orphan drugs. This group will also help the MHLW committee in... Read More

While bribery has been significantly reduced in China’s medical market over the last five years, it still exists. For example, there have been significant reductions of payments to NMPA officials for drug approvals. However, in other areas of the Chinese medical system,... Read More

With over 275 million people, Indonesia is the world’s 4th largest country. Healthcare spending is expected to rise from about $35 per person in 2005 to over $270 per person by 2027. On July 11, the Indonesian House of Representatives announced a... Read More

Advanced healthcare is limited in China due to restrictive pricing schemes that reduce payments. Programs like the drug reimbursement list, diagnosis-related groups (DRGs), and Diagnostic Intervention Packets (DIPs) limit reimbursements and thus make expensive new therapies unaffordable in China. To counter these... Read More

According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More