FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

As the Brexit Clock Ticks Down, MHRA Issues Slew of Guidances

March 29, 2019
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With the UK’s possible exit from the EU approaching, the Medicines and Healthcare products Regulatory Agency (MHRA) released 16 new and revised guidances to cover a no-deal exit scenario.

The agency issued guidance on assessment routes for marketing authorization application evaluations that describes three new routes of evaluation—targeted assessments, accelerated assessments and rolling reviews.

The targeted assessment process is designed to make medicines available to patients more quickly. The MHRA will evaluate submissions and reach a decision within 67 days, the guidance says.

Under the accelerated assessment path — which can be used by all products containing new active substances and those seeking orphan status or a conditional marketing authorization — the MHRA reaches an opinion within 150 days of submission.

The rolling review offers ongoing input to help sponsors “get it right first time” and avoid regulatory snags.

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