Topic:

Regulatory

Latest Headlines

Latest Headlines

U.K. regulators find issues with Indian-owned API distributor Relonchem

U.K. regulators have revoked the license of an Indian-owned API distributor after finding a host of problems at its operations in Cheshire. But the Medicines and Healthcare Regulatory Agency says that Relonchem will be allowed to import some "critical" meds under strict oversight if it is found to be the key supplier.

China plans first-ever rules on animal testing in medical research by year end

Chinese authorities are drafting a national standard expected to be implemented by the end of the year to cover humane treatment of animals used in medical research, including for drug testing. The nation currently has no general rules governing animals in clinical research.

India eases path for small companies to bid in medical product tenders

India's central procurement agency for medicines and other medical products reportedly has lowered some of its standards to allow smaller companies to bid on large contracts for malaria drugs, condoms and other items.

China's SAIC denies probe as reports proliferate on alleged devices crackdown

Three multinational makers of medical devices that together control 80% of China's market for large equipment are said to be under investigation for bribery charges. General Electric, Royal Philips and Siemens reportedly are the targets.

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.