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