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The report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP) indicates that progress continues on a US/EU mutual recognition agreement on GMP inspections. Issues requiring additional discussion before finalization – potentially in early 2017 – the report indicates, include: ● the scope of the provisions ● operational implementation ● the exchange of confidential information between regulators, and ● US proposals not covered in the EU text. The EU reiterated the importance of agreeing on solid regulatory cooperation provisions, stressed the need to maintain a clear commitment to work in areas of strategic interest and to continue collaboration on antimicrobial resistance, according to the report. [For an in-depth review of the mutual recognition discussions, see IPQ September 26, 2016.]
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
