Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT” on medical device management on March 6, 2026. This brings together the provisions of Decree No. 98/2021 and its amendments, including Decree No. 07/2023, into one unified document. The consolidation simplifies how device companies should interpret and... Read More
On July 31, 2025, Taiwan’s Ministry of Health announced a phased plan to digitize drug package inserts, moving everything to a digital and paperless format. By December 31, 2025, all prescription and non-prescription drug inserts must be structured electronically and uploaded to... Read More
In July, Vietnam issued Circular 30, which replaced Circular No. 11/2018/TT-BYT and its amendments with respect to drug quality standards. With respect to quality, drugs in Vietnam need to meet the Vietnamese Pharmacopoeia or the US, EU, British, Japanese, or International Pharmacopoeia.... Read More
On 29 June 2025, the Vietnamese Government promulgated Decree No. 163/2025/ND-CP (“Decree 163”) as part of their revised Law on Pharmacy. Decree 163 came into effect on July 1, 2025, and makes overall revisions in the areas of pharmaceutical regulation, certification of... Read More
On 1 May 2025, Thailand’s Food and Drug Administration (TFDA) launched its new e-Certificate system. Certifications of all health products in Thailand are now online. The system aims to reduce some of the bureaucratic hurdles for manufacturers, importers, and distributors, with quicker,... Read More
On May 16, 2025, the Ministry of Health of Vietnam (MOH) published Circular No. 12/2025/TT-BYT, which substantially changes the drug registration framework in Vietnam. One key change entails the removal of the current fixed listing of over-the-counter (OTC) drugs. Instead, Circular 12 introduces... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has introduced a new initiative focused on three aspects: organoid alternatives to animal testing, legal framework for CDMOs, and the acceleration of GMP inspections. First, the Bio Future Development Council will establish regulations... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
Late last year, Vietnam issued a new law updating and augmenting their 2016 Law on Pharmacy. The updated drug law will simplify some drug regulations and begin on July 1, 2025. On the product registration front, if the drug has been approved... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More