Japan’s MHLW is again proposing to add to the PMD Act the possibility of using real-world clinical data (RWD) for drug approvals. To date, drug approval in Japan has required randomized controlled Trials (RCT). This program was announced by the House Sciences Council subcommittee... Read More
As China’s strong domestic drug R&D programs lead to many new drugs, there will be increased integration between drug companies and China’s health insurance program. Basically, commercial insurance will help Chinese patients pay for high-priced innovative drugs. By the end of 2023,... Read More
The incidence of cancer is growing globally, especially in India. In 2022, the number of new cancer cases in India was over 1.4 million people – slightly less than the figure in the US. Of course, many cases of cancer are never... Read More
Vietnam’s Ministry of Health presented significant amendments to the pharmaceutical law to the National Assembly in June 2024. The 2016 Pharmaceutical Law, which succeeded the 2005 law, initially provided a transparent legal foundation for the pharmaceutical industry and aligned with global standards.... Read More
As mentioned over the last few years, Japan is trying hard to fix its drug lag problem and provide more drug products, more quickly, to its rapidly aging population. At a June 6 MHLW meeting, two new programs were discussed. The first... Read More
Taiwan’s Legislative Yuan passed the “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations” on June 4, 2024. These laws, collectively known as the “Regenerative Medicine Dual Acts,” were ratified by the President on June 19, 2024. They aim to establish a rigorous... Read More
In May, the Thai Food and Drug Administration (TFDA) released new registration guidelines on Software as a Medical Device (SaMD) in Thailand. These guidelines are designed to establish regulations for software-based medical innovations and clarify pathways to reduce uncertainty and expedite market... Read More
On May 28, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the Technical Guiding Principles for Applying Decentralized Clinical Trials (DCTs) in Rare Disease Drug Clinical Development. These guidelines aim to ensure the compliance of... Read More
The Ministry of Health (MOH) recently released a third draft version of a decree to establish a legal framework for managing and developing medical data, creating a National Medical Database, and implementing electronic health records. This decree is open for public feedback... Read More
Drug reimbursement significantly lags drug approval in Korea. This has led to many innovative drugs being approved but not reimbursed for a long time. While the Korean government has made efforts to shorten the reimbursement period over the last 10 years, drug... Read More