China is drafting plans to increase penalties on pharmaceutical companies that manipulate prices, sell counterfeit drugs or otherwise violate pharmaceutical laws. The plans include a credit rating system to incentivize drug firms to lower prices in exchange for access to China’s vast... Read More
The COVID-19 pandemic is hampering the initiation and progress of clinical trials in Asia and around the world. Few patients are entering studies, and trials of new treatments are on hold. In Korea, the number of new patients enrolling in clinical... Read More
China is increasingly emerging as a global leader in cell and gene therapy innovation, with the government granting thousands of patents in the field, and Chinese laboratories already conducting or scheduled to begin more than 1,000 clinical trials over the next two... Read More
Moving to further streamline and modernize its process for reviewing therapeutic products, the Therapeutic Products Branch of Singapore’s Health Sciences Authority (HSA) is instituting a new online documentation process. The new form will allow applicants to file registrations for multiple products through... Read More
New requirements issued in May mandate that pharmaceuticals produced in Indonesia contain at least 30% or more raw materials that are domestically produced. The requirements from the Indonesian Ministry of Industry have been in development for months and have yet to be... Read More
Driven by the needs of its aging population, demand in China for rehabilitation services and institutions is growing rapidly. From treatments for strokes, brain damage, spinal cord injuries and other neurological disorders to post-operative rehabilitation for orthopedic and cardiac patients, the need... Read More
This article was originally published on MedTech Intelligence. With the COVID-19 pandemic shuttering physician offices and walk-in clinics, patients and doctors across Asian markets have turned increasingly to telehealth solutions. The surge is creating a short-term boom—and the likelihood of a long-term... Read More
Tightening government control over the sale of medical devices, Korea is now setting up an authorized period of time that devices can be offered for sale before their registration needs to be renewed. Under the new rule published by Korea’s Ministry of... Read More
Changes to pharmaceutical registration regulations in China that go into effect on July 1 are designed to bolster safety requirements for clinical trials, encourage the development of generic drugs, limit fraud in clinical data and expedite the pharmaceutical approval process. For example,... Read More
As part of its continuing effort to align its regulatory approach to drug registration and regulation with international practices, China is proposing modifications to the way it categorizes pharmaceuticals. The draft plans would be the first restructuring of registration classifications of chemical... Read More