AAMI Drafts Emergency Respirator and Ventilator Medical Devices Guidance in Response to Shortage Due to COVID-19
The Association for the Advancement of Medical Instrumentation (AAMI) released four guidelines yesterday (4/14) from their COVID-19 response team about medical device such as respirators and ventilators to help combat the viral outbreak. The team is made up of...
Face Masks, Social Distancing, and Sheltering in Place: The New Landscape of Global Health in the Fight Against Covid
As Covid continues to spread across the globe, affecting Italy, Spain, and the United States most severely, governmental agencies continue to fight the spread of misinformation surrounding the virus by issuing health safety recommendations. The importance of social...
China Creating a Framework on Real-World Evidence
Purpose of Real-World Evidence/Real-World Data Real-World Evidence is critical for designing more effective treatments. For example, to test new treatments, pharmaceutical companies adopt a method called "Randomized Controlled Trial" (RCT). There are two design groups...
China Finalized the Trade Agreement for Patent Drug with the U.S.
Trade Agreement On January 16, 2020 the U.S. and China finalized the trade agreement that specifies the patent protection rules for drugs. Under the patent protection, biopharmaceutical companies can fill out an application and the term of each new patent is 20 years....
Beigene, the First Pharma Company to Receive FDA’s Approval for Brukinsa
On November 14, 2019, the U.S. Food and Drug Administration gave approval to BeiGene Ltd's lymphoma treatment, Brukinsa. BeiGene is a Chinese biopharmaceutical company that focused on cancer treatments. The treatment "Brukinsa" has been tested on 118 patients with...
China’s National Reimbursement Drug List (NRDL)
What is NRDL? The National Reimbursement Drug List (NRDL) was introduced in 2000 to support medical healthcare and providing patients with basic medical treatments. Between 2000 and 2017, the NRDL has been updated twice, but the reimbursement process is poor. The...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com