On November 14, China’s NMPA announced the document titled “Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders.” These provisions outline the requirements for domestic responsible persons. Imported pharmaceuticals’ quality and safety are... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
China is rapidly becoming a key driver in the development of precision oncology drugs, facilitated by its rising cancer incidence, proactive government policies, and an influx of biopharma investment. China accounted for nearly a quarter of all global cancer diagnoses, with about 5 million... Read More
On October 21, 2024, China’s NMPA rolled out a pilot plan that allows non-end-to-end and segmented production of biologics between different facilities. In the past, the NMPA insisted the entire production process be done inside a single facility. This pilot plan is... Read More
Over the last 5 to 10 years, China has issued a number of anti-corruption regulations that have dealt with healthcare institutions and medical personnel. Corruption has been lowered but still exists. However, on October 11, the State Administration for Market Regulation issued... Read More
Amidst a number of negative healthcare trends in China including competitive locally made products that compete with the West, reduced drug and device reimbursement, the pending Biosecure Act, and increased political frictions, China has announced 2 new policies to help increase foreign healthcare... Read More
China’s National Medical Products Administration has issued a Pilot Work Program to fast-track innovative drug clinical trial approvals. According to the notice, the normal review period has been cut from 60 to 30 working days, and this change will be applied to... Read More
Data transfer in China is generally a difficult process. However, on August 30, 2024, China’s Municipal Cyberspace Administration, Municipal Bureau of Commerce, as well as the Beijing Bureau of Government Services and Data Administration, issued the “Administrative Measures for the Negative List Data Exit... Read More
Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More
The National Medical Products Administration (NMPA) in China has released a draft Medical Device Administrative Law (MDAL) and is soliciting comments from stakeholders. The MDAL is a novel promulgation in China. A notable proposed change is the elimination of the existing country... Read More