Japanese authorities are expected to increase fees in April on mandatory reviews of most categories of new drugs and medical devices. An ordinance drafted by the Ministry of Health, Labor and Welfare (MHLW) proposed increases in fees of up to 28% to... Read More
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
In the wake of the massive recall of a hypertension drug last year, South Korea is stiffening its control of pharmaceutical safety. Beginning immediately, the country’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS), is mandating manufacturers of raw... Read More
Moving to ensure patients can access innovative drugs and medical devices faster, Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to amend the nation’s health and safety laws to speed the development of a fast-track review process. The scope of the... 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
Eager to more tightly control costs to consumers of emerging medical therapies, Japanese authorities are discussing implementing rules to regulate prices on regenerative medicine products At a February 20, 2019 meeting of the Ministry of Health, Labor and Welfare (MHLW), officials for... Read More
Moves by the Japanese government to further regulate the healthcare industry may discourage innovation and deny patients access to cutting edge treatments. Japan, with its universal healthcare system, has the world’s longest life expectancy and ranks highly across a number of health... 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
Three years into a national push to incorporate artificial intelligence and other leading technologies in health services, Japan has had tremendous success. Effectively using big data, healthcare providers in the country are providing support for diagnoses and more effectively using innovative drugs... 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