Local representatives of foreign medical products firms in Hong Kong will be required to strengthen their procedures for handling, storing and delivering medical devices under new guidelines being proposed by the government. The draft rules on local responsible persons (LRPs), who serve... Read More
Seeking to encourage pharmaceutical companies to market urgently needed new drugs already approved in the United States, China’s National Medical Products Administration (NMPA) is waiving the requirement for clinical trials on 30 such therapies. The list published by the NMPA on March... Read More
Moving to give patients faster access to new medicines, the Indian Health Ministry will waive a requirement that new drugs undergo clinical trials in India if they have already been approved in certain other markets. The New Drugs and Clinical Trials Rules,... Read More
Pacific Bridge Medical has just received a verbal message from Hong Kong’s MDCO that a mandatory registration system for medical devices will be put to the Hong Kong Legislative Council later this year and implemented in late 2019 or early 2020. This... Read More
Moving to address a chronic shortage of drug treatments for cancer patients, Chinese health authorities in February announced several new policies to bring urgently needed cancer pharmaceuticals to market. The National Medical Products Administration and the National Health Commission will make it... Read More
The Japanese government is beginning to ease restrictions on drug imports – speeding the review and approval of new products, improving the transparency of the process and widening access to medical data. A streamlined Ministry of Health, Labor and Welfare (MHLW) approval... Read More
Responding to international outcry after a Chinese scientist claimed to have helped create gene-edited babies, China has drafted a series of new regulations on gene editing. The proposed new National Health Commission rules on clinical research address gene editing, gene transfer, and... Read More
The Philippines Food and Drug Administration on April 11 will begin implementing new rules that require registration of most medical devices imported, marketed or manufactured in the archipelago nation. The rules, in the works for more than a year, are expected to... Read More
Moving to align its quality control requirements for medical devices with international standards, South Korea’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS) will begin implementing Good Laboratory Practices (GLP) regulations on medical devices beginning May 1, 2019. The... Read More
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