RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...
  • Regulatory NewsRegulatory News

    How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss

    Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales. The situation in India has reached a point where the Advanced Medical Technology Association ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Scraps 15-day Target for Processing GMP Clearance Applications Australia’s Therapeutic Goods Administration (TGA) has scrapped its 15-day target timeframe for processing good manufacturing practice (GMP) clearance filings. The target is a long-standing part of TGA’s guidelines for overseas manufacturers, but has become progressively harder to achieve as the volum...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pfizer Asks TGA to Rethink Proposed Timeline for Biological Adverse Event Reporting Pfizer has asked the Therapeutic Goods Administration (TGA) of Australia to reconsider proposed timelines for reporting adverse events related to biologicals. The drugmaker wants TGA to mirror the reporting requirements for other medicines, rather than introduce the tighter timelines i...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Novartis and Pfizer Comment on TGA Risk Management Proposals Johnson & Johnson, Novartis and Pfizer say they are broadly in favor of the Therapeutic Goods Administration’s (TGA) proposed framework for risk-management plans, but have some specific suggestions as to how it can be improved. TGA released version 3.0 of its guidance on risk management plans for medic...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Prevalence of Substandard Drugs in India’s Supply Chain Prompts Regulatory Proposals The Indian Ministry of Health has recommended increasing regulatory oversight of government facilities after a survey found 10% of drugs in the state supply chain are substandard. That figure is seven percentage points higher than at retail outlets, raising concerns the government is ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (31 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Security of Connected Medical Devices China Food and Drug Administration (CFDA) has released guidance on the security of connected medical devices. The guidance details the factors companies should consider when seeking to register a device with data storage and exchange capabilities for sale in China. CFDA is aiming the guidance at Class II and...