In its latest move to spur the availability to Chinese consumers of medicines for rare diseases and life-threatening illnesses, China is cutting taxes on some orphan drugs almost entirely. China’s State Council will cut the value-added tax (VAT) rate for some rare-disease... Read More
China’s proposed new Drug Administrative Law (DAL) would significantly strengthen safety requirements for manufacturers of drugs and vaccines, establish a readily accessible repository of drug safety information and increase civil fines for violations. According to a draft of the law, drug manufacturers... Read More
This article was originally featured on Medtech Intelligence. As Asia’s prostate cancer burden grows, so do opportunities for Western medical device companies with products to diagnose and treat the disease. Leading Western medical device firms are moving into markets across the Asian... Read More
In a sign that China intends to increase its scrutiny of foreign medical device and drug companies, its regulators are instituting a process for inspecting overseas medical manufacturing facilities. The new guidelines announced in late December by China’s National Medical Products Administration... Read More
Starting January 1, China began requiring detailed labelling and descriptions in Chinese on most medical device products sold in the country. The new regulations from China’s National Medical Products Administration, the administrative body responsible for the regulation of medical devices and pharmaceuticals... Read More
China’s National Health Commission plans to formulate the country’s first-ever dedicated treatment guidelines for rare disease patients, along with a treatment network and a patient registration system – government authorities announced in January. The announcement by the Chinese government is part of its emerging... Read More
Seeking to codify higher standards for the production, transportation and storage of vaccines, Chinese authorities in January drafted a draft Vaccine Administration Law that would tighten restrictions on vaccines. Under the draft law, companies, firms or non-profit organizations are subject to government... Read More
In an effort to bolster the confidentiality of submissions to its medical device review process, the Chinese government in January 2019 put in place a document registration system applicants may use while seeking approval for their products. The system being implemented by... Read More
Moving to standardize and improve its process of assessing clinical data of new in-vitro medical devices, China’s National Medical Products Administration (NMPA) in late November published new draft guidelines for IVD clinical trials. Firms either renewing or applying for new product registrations... Read More
Just two multinational pharmaceutical manufacturers have been selected to supply drugs to 11 major Chinese cities, as a government pilot program designed to glean lower drug prices goes into effect. The two firms, AstraZeneca and Bristol-Myers Squibb, will supply key drugs at... Read More