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
Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our... Read More
In an effort to improve the quality of medical devices on the Chinese market, the NMPA, led by the National Institutes for Food and Drug Control (NIFDC), will do sampling inspections at various healthcare facilities. Sixty-six product types will be sampled including products... Read More
The Chinese NMPA is very interested in increasing the number of drugs approved in China each year to better serve its citizens. Over the last 8 years, since China joined the ICH and implemented a number of streamlined drug registration regulations, annual drug registrations... Read More
Chinese patients want more drugs to treat their diseases. With over 1.4 billion Chinese people and with more than 350 million people in China’s middle class, there is enough disposable money to pay for them. To get more drugs approved in China,... Read More
Over the last 5 years, getting drugs registered in China and available for sale has become more efficient, easier, and a lot quicker. However, China drug pricing is still a major concern. Two drug price reduction schemes are outlined below. First, one... Read More