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  • Regulatory NewsRegulatory News

    Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

    A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions. Despite the TTIP pause, a spokesman from the EU ambassador told Focus  via email on Thursday evening ...
  • Regulatory NewsRegulatory News

    European Commission Pushes for Closer Convergence With US on Device Regulations

    As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations. The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing...
  • Regulatory NewsRegulatory News

    US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

    US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another's regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports . At issue, the Journal 's Matthew Dalton writes, is that while the US Food and Drug Administration (FDA) is willing to cooperate closely with the European Medicines Agency (EMA) on drug...