Taiwan’s medical device registration system, managed by the Taiwan Food and Drug Administration (TFDA), is known for its well-defined regulatory framework and high standards for safety and efficacy. This process also encourages innovation, especially for digital and smart technology medical devices that... Read More
China’s pharmaceutical market, the second largest in the world, continues to attract international manufacturers of active pharmaceutical ingredients (APIs), excipients, and packaging materials. While the opportunities are vast, accessing this market requires a thorough understanding of China’s Drug Master File (DMF) registration... Read More
Introduction The field of companion diagnostics (CDx) is evolving rapidly in China, driven by advancements in precision medicine and targeted therapies. Companion diagnostics play a crucial role in identifying patient populations most likely to benefit from specific therapeutic agents, particularly in oncology.... Read More
Companion diagnostics (CDx) are essential tools in personalized medicine, ensuring that patients receive the most effective treatments based on their unique genetic and molecular profiles. These tests guide therapeutic decisions by identifying biomarkers, such as genetic mutations, that predict a patient’s response... Read More
Japan’s medical device market is one of the largest and most attractive in the world, offering immense opportunities for foreign companies. However, navigating this market comes with significant challenges that demand strategic planning and a deep understanding of the regulatory environment. This... Read More
China’s healthcare policies have evolved rapidly over the past decade to meet the growing demand for affordable yet innovative medicines. Key reforms, including the National Reimbursement Drug List (NRDL) and the Volume-Based Procurement (VBP) initiative, aim to strike a balance between improving access to... Read More
Many medical device companies try to get their devices into Japan. Japan is the third-largest device market in the world. It is also a very competitive market where only relatively unique and innovative products will succeed there. While many device companies focus on... Read More
Overview of China Reimbursement Over the last seven years, it is now easier to register foreign drugs in China, but drug pricing has generally gone down. China has utilized several programs to reduce drug prices including their National Essential Medicine List (NEML), the... Read More
The pharmaceutical industry in China has seen remarkable growth over the past decade. As one of the largest pharmaceutical markets globally, it offers substantial opportunities for both local and international companies. The demand for both innovative and generic pharmaceutical products is driven... Read More
The Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) play pivotal roles in enforcing pharmaceutical quality standards in Japan. MHLW sets the policies and legal standards, while PMDA is responsible for overseeing the practical implementation... Read More