Moving to better its system for settling patent disputes while also providing generic drugs a market pathway, Chinese authorities in September issued a draft policy addressing the relationship between market approval of generic drugs and the patent status of branded equivalents. The... Read More
To encourage competitive bidding for medical equipment, the Vietnamese government has launched an online portal that makes available to healthcare facilities the prices and specifications of tens of thousands of medical devices on the market. Established in April by the Ministry of... Read More
Thirty-three pharmaceuticals will be added to the 18th edition of the Japanese Pharmacopoeia, if the draft edition of the official compendium of government approved medicines is finalized, as expected. The 33 new products include antibiotics, excipients and biologics, as well as a... Read More
The quality, safety, and efficacy of advanced biopharmaceuticals and regenerative medicines produced and marketed in Korea are subject to a series of new regulations and monitoring requirements under a law that went into effect in August. The Act on the Safety and... Read More
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
As Japan begins to enforce long-anticipated changes to its Pharmaceutical and Medical Device Act, it is ramping up penalties for violations of the new rules, which affect device registration, quality assurances, the regulation of medical software, and third-party certifications. But the changes... Read More
India’s moves to strengthen regulations on the sale of medical devices are creating significant task lists for manufacturers, as registration deadlines approach for obtaining import and manufacturing licenses for devices that did not previously require such approvals. Beginning in November and extending... Read More
Fees to register and obtain licenses for the sale of medical devices in Taiwan will increase next year, the country’s Food and Drug Administration (TFDA) announced in August. Under the new fee structure, registration fees for Class I devices will increase from... Read More
Medical software programs used to prevent, manage, or treat diseases based on clinical evidence are subject to new guidelines for obtaining the approval of regulators in Korea. The guidelines on the digital therapeutics programs cover their definition and scope, criteria for product... Read More