The Central Drugs Standard Control Organisation (CDSCO) has released a draft list to revise the current risk-based medical device classification in India for neurological and cardiovascular medical devices. The CDSCO has invited industry stakeholders to respond to the draft by April 30,... Read More
The Korean Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) are seeking new ways to counteract long registration and market access timelines for healthcare products. Both agencies have been vigorously implementing new ways to get... Read More
On March 25, the National Medical Products Administration (NMPA) and National Health Commission (NHC) officially published the 2025 edition of the Chinese Pharmacopoeia. This new edition contains both traditional Chinese medicines and Western medicines and was reviewed and approved by the 12th... Read More
On April 3, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released guidance clarifying its fundamental outlook on determining “competing products” during drug regulatory reviews. The guidance is intended to promote the integrity and fairness of the drug review process given the possibility of conflicts of interest... Read More
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
In March and April 2025, China’s National Health Commission (NHC) published its first formal guidelines on human genetic resources (HGR) after it took over the regulatory oversight of HGR from the Ministry of Science and Technology (MOST) last year. The introduction of... Read More
On March 19, China’s NMPA promulgated the draft – Interim Implementation Regulations for Drug Trial Exclusivity – with feedback expected by May 18. A similar draft was implemented in 2019, but not put in place due to industry objections. Data exclusivity will include independently... Read More
India is making remarkable strides to transform its regulatory approach to cell and gene therapies (CGT), recognizing that rapidly approving therapies involves engaging more industry stakeholders and approving applications more quickly. At the CAR-T Summit 2025 that took place mid-April in Mumbai, the Drugs Controller... Read More
The Food and Drug Administration (FDA) of the Philippines has released a draft circular suggesting new guidelines for the recall of health products that have been authorized for sale and present a significant risk to public health. The new circular is intended... Read More
Everyone knows that it is getting tougher and tougher to export medical devices to China. While some companies with unique devices are succeeding and making large profits, many companies are not. Unprofitable Western business is a result of a number of factors including... Read More