Basic health insurance plans in China will begin this year to cover the cost of most drugs used to treat rare diseases, according to a National Healthcare Security Administration statement released in December. Under the plan, rare disease drugs that are proven... Read More
A decades-long push by Japan to spur innovation in its pharmaceutical industry is expected to get new life this year, with government health agencies planning to release by this summer a new set of goals for speeding clinical trials and encouraging the... Read More
Twenty-nine new drugs produced by Chinese pharmaceutical companies were added to the new National Drug Reimbursement List (NRDL) in January, squeezing out foreign competitors, whose offerings were deemed by review panels to be exorbitantly priced. The success of such a relatively large... Read More
In a push to speed drug approval times amid the coronavirus pandemic, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is finalizing plans to permit drug companies to supplement or replace their own clinical trials with data from patients who have taken the... Read More
Chinese regulators are clamping down on sweetheart deals between drug and medical device manufacturers and hospitals, in an effort to deter corruption that they fear undercuts the quality of the country’s healthcare. Among the actions taken in recent months are legal proceedings... Read More
Globally, there has been a trend toward using more real-world data in the development of drugs and devices. Japan’s MHLW is also taking note and has drafted 2 new guidelines – 1. A basic policy on using registry data in registration submissions... Read More
Seeking to ensure clinical trials are accurate, credible, and safe while protecting the health of its personnel during the COVID-19 pandemic, Japanese regulators will continue to conduct Good Clinical Practice (GCP) inspections remotely through April 1, 2021. The announcement by Japan’s Pharmaceutical... Read More
Approval times for the sale of medical devices and pharmaceutical products in South Korea are expected to shorten significantly now that two new divisions established to expedite reviews are up and running. The Expedited Review and Pre-Submission Consultation Divisions created by the... Read More
To shorten the amount of time needed for clinical trials of crucially-needed drugs, regulators in China in November issued a draft of technical guidelines to grant conditional approval of critical new treatments. In short, early-phase clinical data can be used to get... Read More
Pushing to speed its historic lag in drug approval times compared with the United States and the European Union, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is bolstering the ranks of its product review staff and making major changes in its approval... Read More