Advanced Therapy Products (ATPs) will be subject to tighter regulation in Hong Kong under an ordinance passed by the legislative council of the special administrative region of China. The ordinance, expected to go into effect next year, requires facilities to obtain a... Read More
New requirements issued in May mandate that pharmaceuticals produced in Indonesia contain at least 30% or more raw materials that are domestically produced. The requirements from the Indonesian Ministry of Industry have been in development for months and have yet to be... Read More
Driven by the urgent need to develop more and better ventilators and other devices to treat Covid-19 patients, South Korea plans to bolster private-sector medical device research in the country with an infusion of government cash and expertise. The research and development... Read More
China’s National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect changes made to the Drug Administration Law... Read More
Spiraling trade tensions between the U.S. and China are injecting uncertainty into what was already a complex environment for MedTech manufacturers. Accelerating steps, some medical technology firms have already been starting to move their operations to other countries in the region. Directly... Read More
Four years after China established a pilot program enabling drug license holders to use third parties to manufacture their products, the National Medical Products Administration in August launched a database to allow drug makers and the public to more easily access information... Read More
As medical devices increasingly flood the Malaysian market, authorities are instituting new regulations that put responsibility for ensuring the safety and efficacy of the products squarely in the hands of manufacturers. The regulations make manufacturers accountable for handling complaints, responding to incidents... 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
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
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