Topic:

Regulatory

Latest Headlines

Latest Headlines

Japan to adopt CDISC clinical data standards from October 2016

Japan's Ministry of Health, Labor and Welfare will require drugmakers to use the Clinical Data Interchange Standards Consortium for submitting clinical trials starting in October 2016, according to a notice issued in Japanese. 

China to lift most drug price controls in move aimed at safety, innovation

Price controls on most drugs sold in China will be lifted in June, the National Development and Reform Commission said on Tuesday, a move signaled earlier by Beijing as a way to tackle issues of safety and to encourage innovation among domestic companies.

From the pharma C-suite: Notable, quotable remarks on Asia, emerging markets for Q1 (Part 5)

FiercePharmaAsia  combs earnings calls by major drug companies for notable and quotable nuggets on emerging markets and Asia to track the latest sales trends and insight into business outlooks in markets as diverse as China, India and Japan to Southeast Asia.

China proposes new rules on safely handling vaccines; detailed company records a must

China's National Health and Family Planning Commission has issued new regulations ordering transparency in the handling of vaccines and vaccination equipment to ensure their safety.

Researchers question safety of off-label device use in atrial fibrillation, call for 510(k) review process

Physicians conducted a systematic review of database reports of the outcomes associated with the off-label use of the Lariat device to prevent stroke in patients with atrial fibrillation. They found several instances of deaths and follow-up emergency surgery, which prompted the researchers to call for an evaluation of the device by the FDA in this indication and to question the safety of the 510(k) clearance process itself.

China probes Siemens Healthcare unit dealers on alleged bribery of hospital officials, Reuters says

China's State Administration for Industry and Commerce is leading an investigation into allegations that hospital officials were bribed by dealers for Siemens AG to exclusively buy company-supplied disposable chemical reagents needed to operate certain medical devices, according to a story by the Reuters news agency.

Shanghai ZJ Bio-Tech gets WHO clearance for Ebola diagnostic kit

Shanghai ZJ Bio-Tech's diagnostic reagent for ebolavirus has been cleared by the World Health Organization for its list of recommended drugs and devices. The China company's diagnostic kit is the third approved by WHO for Ebola.

India, Europe talks on IP tussles break down

India and a group of four European nations, including Switzerland, have broken off trade talks over a failure to resolve differences involving India's protections for intellectual property rights, particularly pharmaceuticals.

From the pharma C-suite: Notable, quotable remarks on Asia, emerging markets for Q1 (Part 4)

FiercePharmaAsia  combs earnings calls by major drug companies for notable and quotable nuggets on emerging markets and Asia to track the latest sales trends and insight into business outlooks in markets as diverse as China, India and Japan to Southeast Asia.

Japan's Eisai, Glenmark settle on Banzel patent dispute

Eisai said it and Glenmark reached a settlement of the Japan drugmaker's U.S. suit for patent infringement of its Banzel (rufinamide) epilepsy drug.