In January 2026, India’s Ministry of Health and Family Welfare made major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. This has shortened the timeline for clinical trial approval from 90 to 45 working days, which will potentially improve... Read More
On January 27, 2026, China’s State Council issued revised Implementing Regulations of the Drug Administration Law of the People’s Republic of China, which will go into effect on May 15, 2026. The regulations refine key provisions of the Drug Administration Law, which... Read More
In late 2025, China’s regulatory landscape for pharmaceuticals changed rapidly due to a number of policies that indicate the government’s commitment to increasing innovation while ensuring adequate oversight and compliance. Recent reforms issued by the NMPA, the State Council, and the National... Read More
China continues to reshape its drug market access system in an effort to balance affordability with better healthcare for its citizens. At the core of this transformation are two reimbursement pathways: National Reimbursement Drug List (NRDL) and Volume-Based Procurement (VBP). Recent policy... Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is strengthening its role as a global regulator by offering more and more registration support for foreign pharmaceutical and medical device manufacturers. The PMDA has established overseas offices, accelerated pathways for product approval, developed harmonized... Read More
The Indonesian medical devices market is one of the largest in Southeast Asia and continues to grow at an accelerating pace as a result of the country’s population growth, increased demand for sophisticated medical technologies, and improved healthcare delivery systems. Indonesia’s regulation... Read More
Due to the rising prevalence of chronic conditions such as cancer and diabetes in China and the increased focus on early diagnosis and reduced treatment costs, the in vitro diagnostics (IVD) market in China is growing rapidly. The National Medical Products Administration... Read More
Recent reforms to medical device registration in China are revamping how innovative products are approved for market entry. Collectively, these measures aim to reduce regulatory hurdles, enhance quality systems, encourage digital transformation, and promote international collaboration. This signals China’s ambition to move... Read More
Over the past year, Japan has initiated a series of regulatory and policy reforms aimed at accelerating drug development, strengthening oversight, and improving access to innovative therapies, while also reinforcing international regulatory cooperation. FY2026 Budget Increase The MHLW estimated budget for FY2026... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) will introduce a new pathway from May 2026, allowing pharmaceutical companies to directly request an eligibility assessment from the Pharmaceuticals and Medical Devices Agency (PMDA) for designation as a “drug for specific use.” The... Read More