The QMN Weekly Bulletin

MHRA Includes GMP, Quality in its Top Priorities

May 5, 2017

The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including ensuring GMP compliance and quality throughout supply chains.

The pathway for this goal includes harmonizing quality standards, inspections and enforcements, and information sharing, MHRA said. The agency will also expand its efforts to address falsified, non-GMP compliant medicines.

The agency developing a model for the agency’s future, post-Brexit. Another agency priority is to devise a five-year plan encompassing national and international strategies for collaboration; delivering the agency’s new Patient Safety and Vigilance Strategy and expanding the services provided by the Clinical Practice Research Datalink.

In pharmacovigilance, MHRA plans to develop a mobile-friendly reporting website for adverse drug reactions and counterfeited medicines, using a formalized methodology for detecting signals, before the end of the year. The agency is also planning a health summit to discuss safety messages in the healthcare system.

Specific deliverables include chairing the International Coalition of Medicines Regulatory Authorities, and developing relationships with China and India. The agency also plans to establish a working group of European regulators to develop a consistent approach to combination products.

Regarding the use of real-world evidence, the MHRA plans to achieve one ongoing pragmatic clinical trial plus one new study before the end of the year, after expanding the use of the agency’s big data software. Additionally, the agency plans to liaise with the FDA and observe its implementation of the 21st Century Cures Act and real-world evidence initiatives.

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