For drug companies planning development in Japan, consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) are a practical way to align your strategy with the Japanese health authority’s expectations before you commit to costly studies and other market entry issues in... Read More
Singapore’s Health Sciences Authority (HSA) has a structured framework for the submission and management of Drug Master Files (DMFs) to support the registration of therapeutic products. Under the DMF system, manufacturers can submit confidential information on drug components while enabling drug product... Read More
Korea has introduced a series of regulatory measures aimed at modernizing its pharmaceutical regulatory framework and improving patient access to innovative products. Recent initiatives from the Ministry of Food and Drug Safety (MFDS) and other health agencies reflect a strategy to incorporate... Read More
According to the Customs Tariff Commission of the State Council, China will begin reducing its import tariffs on several medical goods starting in 2026. The purpose of this policy is to allow for increased access to sophisticated medical technology like artificial blood... Read More
On January 14, Japan’s Central Social Insurance Medical Council (Chuikyo) implemented new pricing regulations for regenerative medicine products that are granted conditional and time-limited approval through a new pricing model. This new pricing model will be applied for the first time to the gene therapy... Read More
On January 15, Singapore’s Health Sciences Authority (HSA) and the Indonesian Food and Drug Authority signed a Memorandum of Understanding (MoU) to improve regulatory cooperation. Both agencies have obtained the World Health Organization (WHO) Listed Authority status, which confirms that they have met... Read More
The National Reimbursement Drug List (NRDL) for 2025 has been announced by the Chinese government and includes 114 new entries, 50 of which are first-in-world innovative therapies. These additions show an increased focus from the government on making high-value medicines available to... Read More
In December 2025, Malaysia’s Medical Device Authority (MDA) published for public comment its draft First Edition of Guidance on the management of changes to registered medical devices. This guidance is an important milestone in how modifications to registered medical devices will be... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has released the final list of risk classifications for oncology-related medical devices. The classification system, published on January 2, 2026, improves transparency concerning the regulation of cancer med-tech devices. It gives manufacturers of oncology devices... Read More
The Singapore Health Sciences Authority (HSA) has introduced regulatory updates to help clarify and streamline the registration of Therapeutic Products, effective January 16, 2026. Key updates include: A new pathway for submitting Standard Essential Medicines as a Generic Drug Application (“GDA”) for... Read More