Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Posts Guidance on How to Manage and Communicate Drug Shortages   Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.   TGA proposed moving to a mandatory model in Apri...

Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices. The recall affects six pacemaker models—Accent, Accent MRI, Accent ST, Allure, Anthem and Assurity—that Abbott acquired when it completed its purchase of St. Jude Medical last January. Patients with the devices are being told to speak to their doctors to determine whether they should recei...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (...

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation. The warning letter for the Sylmar, CA-based site, which manufactures implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, followed a 10-day FDA inspection in February. FDA previously issued a Form 48...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Proposes Change to Rare Disease Threshold in Orphan Drug Rethink The Therapeutic Goods Administration (TGA) of Australia is proposing to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only...

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China. After a career as a researcher at the Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention (China CDC), Bird Shi became a regulatory affairs director at one of the world's top 500 enterprises. She has witnessed how the regulatory system of China's food industry has improved since its founding and although regulatory affa...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott Contests Indian Allegations of Substandard Cough Syrups A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on t...

Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. The proposal, part of a new government  position paper pushing innovation and competitiveness issues, wou...

Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary recall for all its blood glucose meter devices, citing the same core defect that led to last month's recall of a similar product manufactured by Johnson & Johnson. Background On 25 March 2013, Lifescan, a subsidiary of Johnson and Johnson, issued a recall of nearly 2 million...

Officials with Abbott Laboratories have announced the suspension of a controversial policy that has stoked controversy with critics who claim the company is buying favors from prescribing physicians by lavishing them with valuable gifts, reports Reuters . In an email obtained by the news organization, Abbott Healthcare, a subsidiary of its North American counterpart, said it would henceforth only distribute approved literature to prescribing physicians. "No brand ...

Life sciences manufacturer Abbott has pleaded guilty to charges of unlawfully promoting its anti-seizure drug Depakote (divalproex sodium) and will pay a total of $1.5 billion in fines and be subject to a five-year probationary period, the Department of Justice (DOJ) announced on 2 October. Under the settlement, Abbott will pay a $500 million criminal fine, forfeit $198.5 million in earnings and pay $800 million to state and federal government. The fines and penalties...

An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...