In January, the Thai Food and Drug Administration (Thai FDA) released updated Change Notification Guidelines for In Vitro Diagnostic (IVD) products. The new guidelines took effect on January 15, 2025. To add medical device items, manufacturers must submit change requests that must be... Read More
In mid-February, China’s Center of Drug Evaluation (CDE) under the NMPA promulgated two new guidelines. The first guideline was titled – The Guideline for Acceptance and Review of Chemical Drug Registration (trial) – which will begin on March 10 of this year. This... Read More
The Korean Ministry of Food and Drug Safety (MFDS) plans to continue strengthening its support for innovative medical products, including new drugs, advanced biopharmaceuticals, and medical devices. The effort is meant to expedite the development and market release of innovative healthcare solutions. At a... Read More
On February 26, the Japanese Health Science Council’s sub-committee on clinical trials set up an FMV pilot program to study clinical trial costs at designated Japanese hospitals. The pilot program will be done in Japan’s fiscal year 2025 which starts in April. This... Read More
On February 21, 2025, Korea introduced the Regenerative Medicine Law, which will enable patients suffering from serious, rare, or untreatable diseases to gain access to cell and gene therapies that are not yet fully approved for marketing. The law’s full title is ... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) is loosening a policy regarding post-approval changes in manufacturing, allowing pharmaceutical companies to submit “annual reports” rather than “minor change notifications” for minor changes with minimal effects on product quality. The relaxation of this rule... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) granted orphan drug designations to 15 drug compounds on February 28, including Novartis Pharma’s atrasentan for IgA nephropathy. Other drugs given this designation include Alexion’s efzimfotase alfa (hypophosphatasia), HanAll Biopharma’s batoclimab (thyroid eye disease),... Read More
According to a recent survey in Japan, based on published documents and press releases as well as discussions with drug companies and the Japan Pharmaceutical Manufacturing Association, 43 novel drugs will be approved and receive NHI pricing in 2025. This will be a... Read More
The Singapore Health Sciences Authority (HSA) has published updated guidance for its Change Management Program (CMP) Pilot for Software as a Medical Device (SaMD). This program aims to make the regulatory pathways for post-market changes to SaMD more efficient, balancing patient safety with... Read More
About 7 years ago, China initiated a volume-based procurement (VBP) policy to award drug companies with large sales opportunities but at significantly lower prices – oftentimes, VBP winners have drug price discounts of 50% to 90%. There have been 10 rounds of VBP... Read More