Archives
CDx Registration in Korea, Taiwan, Singapore, Australia, and the Other Asian Markets
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more. Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of... Read More
Japan CDx Registration
Pacific Bridge Medical has worked with a number of Western CDx companies to address the above issues and register CDx products in Japan. Please contact us to learn more. As medical care becomes more personalized, more drug companies are looking to utilize... Read More
China CDx Registration
Please contact us to learn about how we can help you register your CDx product in China. Using Western CDx products, drug companies and their specific drug products can more easily target the right patients with specific diseases. Unfortunately, CDx registration in... Read More
China Drug Master Files for API, Excipient, and Drug Packaging Material Manufacturers
Contact us to learn how we can help you with DMF registration in China. API, excipient, and drug packaging manufacturers that want to protect their intellectual property and manufacturing processes will want to do a China DMF. Manufacturers with EU CEP, US... Read More
Japan Takes Additional Steps to Expedite SaMD and AI Products
The Japanese government is considering a new program to shorten the approval review for software as a medical device (SaMD) and AI products. Currently, approval of these types of products can take several years in Japan. With the new regulations, approvals could... Read More
China Cracks Down on IP Issues for Pharmaceutical Procurement
More and more drugs are purchased by Volume Based Procurement in China today. In exchange for large volume sales, prices have dropped for many drugs by 50-90%. Sometimes, the winners of these procurements sell drugs with patent infringement. To avoid this issue,... Read More
Singapore Updates Special Access Routes (SAR) for Unregistered Class D Devices
In January, Singapore’s MOH updated GN-26 and GN-27 SAR for non-registered medical devices. Doctors, medical institutions, and labs can now more easily import non-registered Class D devices that are new or have new indications, or are new implants. Certain categories of non-registered... Read More
New Measures Affect Export of Pharmaceutical Data from China
Getting drug and patient data transferred from China to the West is not an easy process. Data transfer requires approval from China’s Ministry of Science and Technology (MOST). Drug companies need pre-approval or record filing with the Human Genetic Resources (HGR) Administration... Read More
Japan Planning to Maintain Pharmaceutical Prices for Innovative Drugs in April 2023
Like most countries, downward drug pricing is the rule of thumb. If there is a discrepancy in Japan between NHI prices and market prices, normally a revision is done. While historically, Japan only adjusted drug prices every 2 years, recently that has... Read More