The MHRA is producing guidance on coronavirus (COVID-19) for industry. The Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with Department of Health and Social Care and other healthcare partners on COVID-19.
They are prioritising work including:
- Supporting and authorising the development of vaccines
- Clinical trials of new medicines
- Managing the supply of medicines and healthcare products.
They are also providing information to patients, manufacturers and healthcare professionals through their established information channels and alert systems.
The National Institute for Biological Standards and Control (NIBSC), part of the MHRA, also plays a major role in assuring the quality of biological medicines, worldwide.
The MHRA Inspectorate blog has several posts covering the approach taken on clinical trials and advice on other areas like remote working.
- Respiratory status of equipment being used to help prevent coronavirus – NEW
- Managing clinical trials during Coronavirus (COVID-19) How investigators and sponsors should manage clinical trials during COVID-19
- Clinical trials applications for Coronavirus (COVID-19) The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19.
- New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19) MHRA will only be conducting essential inspections. They are expecting organisations to maintain GxP compliance.
- Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
- Regulatory approval for Coronavirus (COVID-19) test kits How manufacturers can submit COVID-19 test kits for regulatory approval to MHRA.
- Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions.
- Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak Fast-track approval of medical devices during COVID-19 outbreak.
- Chloroquine and Hydroxychloroquine are not licensed for coronavirus treatment.