Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.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....
Tracking the Coronavirus With AI: How JHU & BlueDot are Leading Pre-vaccine Outbreak Response
To understand and control the spread of the latest coronavirus (2019-nCOV), a vast array of artificial intelligence and natural language processing tools have been deployed, giving those watching from the Health Sciences field good cause to be optimistic about recent...
The New Science of Arthritis
“Arthritis” does not stand for one single disease, but multiple joint pain or joint diseases. Arthritis is one of the leading diseases that caused physical deformities and disabilities. There are more than 100 different types of arthritis that affect tens of millions of people from…
HEALTHY 2020 We Are One World
CSOFT celebrates the year of the Rat Now that 2019 is behind us, we have an opportunity to reflect on how far we’ve come. As we leave behind a year of drastic change, innately global issues continue to challenge us, for example, the Coronavirus. This virus has caused...
Raising Awareness of Mental Illness
Overview of Mental Health Mental illness is a medical condition that affects changes in emotion, thinking, and behavior. Mental disorders can affect anyone regardless of their age, gender, sexual orientation, and race. Also, it can happen at any age, but the most...
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...
China Introduces Structural Changes to Pharmaceutical Regulations
Beginning of Changes China revised its pharmaceutical regulations by releasing the second draft of the Drug Administration Law of the People's Republic of China (DAL) to the Committee of the National People's Congress of China (NPC) for discussion. The first draft...
FDA Reducing Price of New Drugs Through Drug Competition Action Plan
The Theory At the American Society of Clinical Oncology (ASCO), FDA Commissioner Dr. Scott Gottlieb introduced the Drug Competition Action Plan, which aims to lower new drug pricing by increasing generic (alternative) drug competition in the pharmaceutical market....
China’s New Human Genetic Resources Policy
CHINA’S NEW HUMAN GENETIC RESOURCES POLICY New Regulation Underway On May 28, 2019, the Chinese government published new regulations on the management of Human Genetic Resources (HGRs). The main objective of the government is to observe all HGR- related activities,...
Categories
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