China’s pharmaceutical sector has been undergoing significant transformations in the past year, with sweeping reforms affecting drug reimbursement, approval processes, market access pathways, and the oversight of pharmaceutical representatives. Together, these policy shifts aim to enhance access to high-quality treatments, increase efficiency... Read More
Japan’s healthcare system is known for its efficiency and centralized regulation, which also extends into its medical device reimbursement process. For foreign and domestic manufacturers alike, understanding Japan medical device reimbursement framework is essential for successful market entry and sustained commercial success.... Read More
Japan maintains one of the most rigorous and structured Good Manufacturing Practice (GMP) compliance frameworks globally. Designed to ensure the safety, efficacy, and quality of drugs and quasi-drugs, Japan’s GMP regime is enforced by the Pharmaceuticals and Medical Devices Agency (PMDA), under... Read More
South Korea has long stood at the forefront of technological advancement in Asia, with a robust healthcare system and a rapidly growing digital health ecosystem. In line with its reputation as a global innovator, South Korea has recently introduced several major regulatory... Read More
Introduction Singapore’s medical device regulatory framework is considered one of the most transparent and robust systems in the Asia-Pacific region. Managed by the Health Sciences Authority (HSA), the regulatory process aims to ensure the safety, efficacy, and quality of medical devices entering... Read More
Malaysia has developed a robust and evolving regulatory system to govern the safety, efficacy, and quality of medicinal products. At the core of this system is the 1984 regulation – Control of Drugs and Cosmetics Regulations (CDCR). These regulations set the legal... Read More
Malaysia’s healthcare sector continues to grow rapidly, supported by a robust regulatory environment aimed at ensuring the safety, quality, and performance of medical devices. Central to this framework is the Medical Device Act 2012 (Act 737. Under this Act, all medical devices... Read More
The Drug Master File (DMF) system in Japan serves as a critical regulatory mechanism enabling pharmaceutical manufacturers, both domestic and foreign, to confidentially register the quality and manufacturing data of drug substances, intermediates, and related materials with Japan’s review authority. Managed by... Read More
Navigating regulatory landscapes can be daunting, especially when dealing with proprietary drug substance information. For pharmaceutical companies planning to register therapeutic products in Singapore, understanding the requirements of a Drug Master File (DMF) is essential. In August 2024, Singapore’s Health Sciences Authority... Read More
Introduction Regenerative medicine is an innovative and rapidly evolving field that leverages genes, cells, and their derivatives to reconstruct or repair human body structures and functions, ultimately aiming to treat or prevent diseases. This field has the potential to revolutionize healthcare by... Read More