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MHRA details wide-ranging flexibilities amid COVID-19

Posted 02 April 2020 | By Michael Mezher 

MHRA details wide-ranging flexibilities amid COVID-19

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week outlined wide-ranging “regulatory flexibilities” to better facilitate the response to the coronavirus disease (COVID-19) pandemic.
The flexibilities extend to clinical trials, inspections, drugs and medical devices and include relaxed requirements and expedited services in areas to support the development of products for COVID-19 and to ensure the UK’s supply of other medical products during the outbreak.
MHRA says the flexibilities are temporary and take effect immediately upon announcement.
Some of the flexibilities outlined in the list include ones previously detailed by MHRA and follow other actions taken by the regulator in response to the pandemic including shifting meetings to teleconferencing, barring certain drugs from parallel export, lowering standards for ventilators and issuing advice on managing clinical trials amid the outbreak.
Clinical Trials
For clinical trials, MHRA says it is offering expedited scientific advice and rapid reviews for clinical trial applications for treatments for COVID-19.
The agency also offered flexibilities to reduce certain reporting requirements and ease rules for obtaining informed consent and patient monitoring.
MHRA further clarified that sponsors do not need to report an increase in protocol deviations as serious breaches of their studies.
Inspections, Testing and Qualified Persons
While MHRA previously announced it will halt routine onsite inspections during the outbreak, the agency this week eased requirements for importing medicines from third countries and says it will prioritize certifications for certain qualified persons (QPs).
Under the policy, certain re-testing activities should not be carried out if the testing will lead to delays or shortages, though such testing “should continue whenever possible.” MHRA outlines two examples of how this flexibility could be practiced, including not re-testing batches that were fully tested in another Pharmaceutical Inspection Co-operation Scheme (PIC/S) country and performing less re-testing for products manufactured in non-PIC/S countries “if fully tested to equivalent standards by the third country manufacturer.”
The policy also allows for QPs to fully omit re-testing on importation using a “risk-based retrospective skip lot approach.”
“Quality attributes that have failed import re-testing should continue to be tested for all imported batches until robust preventative actions have been implemented and confirmed by the QP,” MHRA writes, noting that specialist analyses for biological products should continue on importation.
MHRA urges QPs that run into logistical challenges to report any difficulties as soon as possible.
Additionally, MHRA says it will prioritize QP certification variations to add replacement QPs to a manufacturer’s authorization (MIA) and a manufacturer’s authorization for investigational medicinal products (MIA/(IMP)).
Drugs and Medical Devices
For both drugs and medical devices, MHRA is providing certain expedited services during the COVID-19 outbreak.
MHRA says it will expedite its assessment of national variations and initial applications for any medicines that may impact the country’s supply chain. For now, MHRA provides dedicated email addresses for requesting expedited assessments for variations and applications and says it is preparing guidance on the matter.
Expedited advice will also be offered for all medical device enquiries related to COVID-19. MHRA also says it is processing exceptional use applications for medical devices to allow non-CE marked medical devices for priority needs, including ventilators and personal protective equipment (PPE).
The agency is also extending the deadline for drugmakers to submit nitrosamine risk evaluations by six months.

Tags: coronavirus

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