On July 31, the Standing Committee in Guangdong Province promulgated a new regulation to expedite the approval of urgently needed drugs and devices into China – for products that are already approved in Hong Kong or Macao. The regulation is titled –... Read More
The Japanese MHLW has increased its budget by over $3 billion for fiscal year 2025. The extra funding will be used to enhance the development of promising drugs and medical devices. Part of the budget will be allocated to building a stronger... Read More
In late July, China announced a new trial program, starting in August 2024 for one year, to reduce the IND review time for innovative drugs in China to 30 days. Previously, the IND review time was 60 days and if an applicant... Read More
In mid-June, the Chinese NMPA promulgated a new guideline on a trial basis to standardize inspections of device clinical trial sites. In the past, device clinical trial oversight has been somewhat lax, and these guidelines hope to improve the safety and quality... Read More
In late May, China’s CDE under the NMPA, promulgated a new program for rare diseases called the – Patient-Centered Action for Rare Disease Encouragement (better known as the Care Plan). This pilot program focuses on the “rare disease patient” and is geared... Read More
As China’s strong domestic drug R&D programs lead to many new drugs, there will be increased integration between drug companies and China’s health insurance program. Basically, commercial insurance will help Chinese patients pay for high-priced innovative drugs. By the end of 2023,... Read More
On May 28, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the Technical Guiding Principles for Applying Decentralized Clinical Trials (DCTs) in Rare Disease Drug Clinical Development. These guidelines aim to ensure the compliance of... Read More
In an attempt to help innovative drug developers get payback for their R&D efforts to bring new innovative drugs to the market and get compensated fairly, both Japan and China have initiated some new innovative drug pricing plans. In late May, the... Read More
In mid-May, the Chinese NMPA issued a new IVD Reagent Classification Catalogue. The new catalogue has over 25 primary product varieties and over 1,800 secondary varieties. A number of specific reagent sub-categories are further defined including staining solutions, cell culture media, etc. IVD reagent... Read More
At several recent government meetings in China, there have been discussions on how to price innovative drugs. As of now, the NMPA defines an innovative chemical drug as a drug that has a new compound, increased clinical value, etc. This definition is... Read More