A claim by the leading U.S. pharmaceutical industry lobby that South Korea unfairly favors its own drug manufacturers over foreign firms is receiving strong pushback by the Korean government. Earlier this year, Pharmaceutical Research and Manufacturers of America (PhRMA) argued to the... Read More
This article was originally published on MedTech Intelligence. Last year, Research and Markets released a report projecting that China’s in vitro diagnostics (IVD) market is likely to triple in size before 2022. This growth is driven by an aging population, a growing... Read More
Up until now, China has only had a few Diagnosis-Related Groups (DRGs), and they have not been a factor in China’s healthcare scheme. However, in February 2018, China’s Ministry of Human Resources and Social Security (MoHRSS) released a list of 130 diseases... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More
This presentation provides an overview of the regulatory framework and drug registration process in India. To view these presentation slides, please click on Drug Registration in India Presentation. Table of Contents: Regulatory Framework in India FDC Registration Process in India... Read More
Historically, device reimbursement in Korea, when available, has been about 50% of what it is in the West. The Korean Health Insurance Review and Assessment Service (HIRA) is planning to regroup medical device categories that are listed for reimbursement. The first regrouping,... Read More
According to leaked reports, China’s Ministry of Human Resources and Social Security (MoHRSS) is planning to announce 300 additions to the National Reimbursement Drug List (NRDL), which is a list of drugs covered under the country’s national insurance plan. The NRDL has... Read More
Even as China’s economic growth slows, its middle class is expected to continue expanding rapidly. As people get wealthier, one thing they consistently demand more of is healthcare. At present, less than 10% of people in China have private health insurance, and... Read More
In February 2016, South Korean lawmakers passed an amendment that allows the National Health Insurance Service (NHIS) to collect damages from pharmaceutical and medical device companies that violated data reporting guidelines. Under this new amendment, the NHIS can collect insurance losses from... Read More