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www.fdanews.com/articles/9908-mhra-outlines-2016-2017-business-plans

MHRA Outlines 2016-2017 Business Plans

May 1, 2016

The UK’s Medicines and Healthcare products Regulatory Agency plans on taking a global leadership role in surveillance and regulation of devices, focusing on:

  • Extending the yellow card reporting application to medical devices, defective medicines, and counterfeit products;
  • Developing incident and safety reporting systems;
  • Supporting DH in GS1— which includes the Unique Device Identifier — and PEPPOL standards for medical devices;
  • Securing EU agreement on new medical devices and in-vitro diagnostic devices regulations to align with UK priorities and European Affairs Committee clearance;
  • By March 2017, introduce fees for medical devices, subject to HM Treasury agreement;
  • Providing leadership IMDRF initiatives such as Medical Devices Single Audit Program and Medical Device Nomenclature Working Group; and
  • Continue to develop its collaboration through the Medicines Industry and Medical Devices Liaison Groups (MLG and MDLG), emphasizing regulation and burden reduction throughout Parliament.

To read the report, visit: www.fdanews.com/05-02-16-MHRA-report.pdf. ― Joya Patel