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.
The British Pharmacopoeia has published a statement on its products and services during the outbreak, including some actions for any British Pharmacopoeia Chemical Reference Substance (BPCRS) customers who are ordering any substances classified as controlled drugs or precursor chemicals.
Clinical trials
- Managing clinical trials during Coronavirus (COVID-19)
- Clinical trials applications for Coronavirus (COVID-19)
- All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up – NEW
- Anaesthetic machines: off-label use during the COVID-19 pandemic – NEW
Medical devices
- Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak
- Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
- Guidance on coronavirus (COVID-19) tests and testing kits
- Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
- Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
- Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
- Regulatory approval for Coronavirus (COVID-19) test kits
Medicines and COVID-19
- Coronavirus (COVID-19) and high blood pressure medication
- Chloroquine and Hydroxychloroquine are not licensed for coronavirus treatment.
- Ibuprofen use and Coronavirus (COVID-19).
Inspections and good practice
- Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak – NEW
- Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak – NEW
- Information for hospital blood banks during the coronavirus (COVID-19) outbreak
- Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak
- Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak
- Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
- New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)
- Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak
Regulatory flexibilities
Keep up to date with our news on COVID-19 and coronavirus.
