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UK’s medicines regulator resumes onsite inspections

The global pandemic saw the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) suspend its inspection program in January 2021. This decision was taken in line with government restrictions related to social distancing and travel. However, as of March 29 the inspectorate resumed its inspection programme, allowing the MHRA to fulfill its public health duties.

In its update, the MHRA made clear that the onsite inspections will happen two weeks after the inspectorate has formally notified those concerned to allow them to prepare their facility. However, the update stressed that it does not expect verified copies of paper data, nor does it expect a physical inspection backroom, but personnel should be available to facilitate – albeit not necessarily in person. There will be a requirement for sites to provide and adhere to social distancing measures and provide documents via electronic means.

Since the beginning of lockdown, the MHRA has carried out more than 750 remote inspections. However, the regulator said that remote inspections actually take more time to perform compared with onsite inspections due to technological limitations.

Paula Walker, operations manager of the MHRA GCP Inspectorate, highlighted[1] the importance of physical inspections: “I have found the consensus view across global regulators is that working remotely is a great tool in our inspection toolkit, but will never replace what can be achieved in person – and there are many areas that are just not suitable for remote approaches, such as sterile facilities.”

As the vaccine rollout picks up the pace, it is likely that the MHRA will look to increase its in-person visits. However, until then it will have to continue its work using a blended model. It remains to be seen if any significant problems will arise due to the MHRA being unable to visit sites because of the pandemic. Indeed, we won’t know the answer to this conundrum until the end of 2021, when we can make year-on-year data comparisons.



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