COVID-19 Guidance

27 May 2020

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Updated: 27th May 2020
In response to the Covid-19 outbreak, we have assembled this page to provide updated information and links to useful resources in relation to medicines development and the ongoing supply of licensed medicines during the global pandemic.

Investigational Medicines and Clinical Trials

Investigational medicines in development for COVID-19

The MHRA will prioritise CTA applications for COVID-19 related trials according to the guidance provided in the following link... click here

EMA Support for developing vaccines and medicines treating COVID-19... click here

EMA FAST-TRACK support and approval for COVID-19 related medicines and vaccines

The EMA describes the measures that it is putting in place to support the faster devvelopment and approval of COVID-19 related medicines. These measures include:

GLP and COVID-19

Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)GLP during COVID-19...click here

Clinical trial applications and trial management

Clinical reporting (missed data etc, halting /restarting trials due to COVID-19) and GCP... click here

EMA advice and guidance for clinical trials during COVID-19
ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19#advice-on-clinical-trials-section
and
ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

Draft guideline: Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials... click here

Medical Devices

MHRA and COVID-19 test kits

COVID-19 test kits: MHRA provides initial specifications for tests and testing kits and advice for members of the public... click here

MHRA and devices exemptions

MHRA provides advice regarding the exemptions from devices regulations during COVID-19... click here

Licensed Medicines

MHRA provides advice on flexible regulatory measures

• Added information in the ‘Medicines regulation’ section on further flexibility around labelling, the limit for replies to questions on Type IB variations and the extension of the 30-day national phase for DCP CMS.
• Suspending the 30-day limit for replies to question on Type IB variations
• Extending the 30-day national phase for DCP CMS applications. If requested by the company, we will hold the application with the clock off until all documentation is available.
• Waiving the requirement for leaflet mock-ups to be submitted to support variations. Text versions will be accepted and these will be uploaded onto the MHRA Products website. This does not apply to 61(3) applications.
• We will consider over-labelling of foreign language packs for UK market on a case-by-case basis.

For further details... click here

Exceptional GDP

MHRA provides guidance for industry on flexible approaches we are taking on good distribution practices...click here

Specials Pack down

MHRA says that pharmacies wishing to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions...click here

EMA Nitrosamines risk assessments extended due to Covid-19

The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders from 26th March 2020 to 1st October 2020... click here

Remote Working and QP batch certification

In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and although some companies employ a part-time or contract Qualified Person (QP), there is still a need to maintain market supply whilst the QP fulfils their other duties or is restricted from travel.
The QP must be able to demonstrate they are fulfilling their wider duties.
• Where remote QP certification is employed, it must be described and controlled within the pharmaceutical quality system.
• Accurate and up-to-date information must be available to support batch certification and release.
click here

Due to the COVID-19 pandemic, further guidance has been provided for electronic approval processes.
Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable. Alternative methods are described to maintaining basic control of documents for organisations involved in the pharmaceutical lifecycle (GMP, GDP, GLP, GCP & GPvP) or GLP studies regulated by the MHRA...
click here

MHRA Electronic PDF licences and certificates

The MHRA staff are now all working from home so they are issuing electronic pdf copies of licences and certificates, however entries will continue to be uploaded to EudraGMDP... click here

MHRA Yellow-Card warning system

The MHRA Yellow-Card system has been extended to include a dedicated facility to report suspected side effects to medicines or medical device and diagnostic adverse incidents used in coronavirus treatment to the Medicines and Healthcare products Regulatory Agency to ensure safe and effective use. Follow the two links below for more information...
coronavirus-yellowcard.mhra.gov.uk

gov.uk/drug-safety-update/coronavirus-covid-19-new-dedicated-yellow-card-reporting-site-for-medicines-and-medical-devices

27 May 2020

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