Last year, the China Food and Drug Administration (CFDA) issued draft rules on clinical drug trials aimed at bringing its system more closely in line with international norms. Among the key changes proposed, clinical drug trials will be subject to a 60-day... Read More
The China Food and Drug Administration (CFDA) has proposed two draft circulars on conditional approvals for urgently needed drugs and the compassionate use of investigative drugs in China. The two drafts, if approved, would increase market access for new drugs and innovative... Read More
China’s Food and Drug Administration (CFDA) is removing a requirement that Innovative Medical Devices—defined as new technologies not available in China—must have regulatory approval in their country of origin to qualify for registration. Manufacturers of these devices will no longer have to... Read More
India’s government will release a Uniform Code for Medical Device Marketing Practice (UCMDMP) as it prepares to implement new regulations in January 2018. Medical devices in India have been regulated as pharmaceuticals, but the new rules will treat them separately. Under the... Read More
On October 23, 2017, Taiwan’s Food and Drug Administration (TFDA) announced a new online platform to speed up the registration and review time for pharmaceutical products. Until now, pharmaceutical companies had to mail the necessary documents in paper and in electronic copies... Read More
China regulations for medical registration could be easing soon. On October 8, 2017, new regulations from the State Council were issued. The proposed changes are not yet law. For both drugs and devices, the proposed changes will include: Acceleration of the CFDA... Read More
Recently, Japan’s Health Ministry has provided approval for telemedicine when treating certain conditions. For example, smoking cessation patients will no longer need an initial face-to-face examination, and will no longer need to see a doctor for prescription drugs to stop smoking. Doctors... Read More
This article was originally published on MedTech Intelligence. Approximately the third largest in the world, China’s medical device market is currently worth about $21 billion. However, given the country’s large geographic area, fragmented markets and thousands of medical device distributors, the search... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
Korea’s main regulatory body, the Ministry of Food and Drug Safety (MFDS), expanded its qualifications for what is classified as an “exempt medical device.” This amendment was made to conserve the time and resources wasted on accounting for changes that have insignificant... Read More