Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
In my last mini blog (COVID-19 – Regulators Respond – EU Focus) we looked at how the the EMA is responding to the COVID-19 pandemic and, specifically, what flexibility they are offering to support the pharmaceutical industry.
Today we shall focus on the UK.
The MHRA have expedited scientific advice and reviews of CTAs to support research and manufacturing of potential COVID-19 treatments. They have also expedited variations assessments and initial applications which affect the medicines supply chain.
The MHRA has extended the deadline for updates to product information following safety reviews by 3 months (including national variations and implementation dates) except in the case of significant public health issues.
They are also accepting text versions of labels and leaflets instead of mock-ups to support variations, (this does not apply for 61 (3) applications).
The 30 day deadline for responding to questions on Type IB variations has been suspended.
The implementation time for label and leaflet changes following a variation has been extended from 6 months to 9 months. This does not apply for significant safety updates.
The 30 day national phase for DCP applications has been extended.
Regarding PSURs: Postpone or waive requirement of submission of PSURs for actives authorised only in UK, that is those not on the EURD list.
Submission frequencies/dates can be amended accordingly.
Regarding Renewals, the MHRA are offering flexibility in submission date with no automatic lapse of national MAs due to lack of submission of a renewal application.
MHRA conducting a combination of on-site and remote GMP inspections from September 2020.
For holders of Specials licences the MHRA are permitting the ‘pack down’ of large packs of licenced medicinal products into smaller quantities for retail sale by pharmacies.
Regarding Devices: Where feasible, audits of Notified Bodies and manufacturers have been delayed. Remote audits and reviews are being considered as alternatives. Exceptional use applications are being processed to ensure a continued supply of non-CE Marked Medical Devices where there is a significant clinical need and where there are no CE Marked Devices available.