New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)

As part of our response to the coronavirus outbreak, we have decided to conduct only essential Good Practice (GxP) inspections of Laboratories, Clinical Trials, Manufacturing, Distribution and Pharmacovigilance until further notice.

Other MHRA inspections will be deferred to a later date.

Our Good Practice inspections monitor compliance with the MHRA’s UK standards in sites engaged in laboratory studies, clinical trials, manufacturing, distribution, and pharmacovigilance (safety monitoring of medicines). They are conducted both in the UK and overseas.

We are expecting organisations to maintain GxP compliance, and will support the industry and NHS to focus on service continuity by using alternative approaches for routine regulatory oversight, such as office-based assessment and the sharing of information within the international regulatory network.

We will prioritise essential on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk, where these sites cannot be assessed remotely. Essential clinical trial authorisation applications will not be affected by this change and will remain prioritised.

We understand current challenges, and are acting in line with UK Government recommendations to minimise the impact of any such inspections on industry and agency personnel wherever possible.

This situation remains under review and we will provide further information as it becomes available.

If you have any questions on GxP-related issues, please email:




North Shropshire Electricity Distribution Network granted development consent

Development consent has been given for the installation of a new 132kV overhead line Trident design, comprising of 3 conductors supported by mostly single wood poles. The site is located from Oswestry Grid Substation to Wem Primary Substation.

The application was submitted to the Planning Inspectorate for consideration by SP Manweb on the 12 November 2018 and accepted for examination on 10 December 2018. Following an examination during which the public, statutory consultees and interested parties were given the opportunity to give evidence to the Examining Authority, a recommendation was made to the Secretary of State on 20 December 2019.

The Planning Inspectorate’s Chief Executive, Sarah Richards said:

This is the 82nd nationally significant infrastructure project to have been examined and decided within the timescales laid down in the Planning Act 2008. The Planning Inspectorate is committed to giving local communities the opportunity of being involved in the examination of projects that may affect them. Local people, the local authority and other interested parties were able to participate in a 6-month long examination. The Examining Authority listened and gave full consideration to local views before making their recommendation.

The decision, the recommendation made by the Examining Authority to the Secretary of State and the evidence considered by the Examining Authority in reaching its recommendation is publicly available on the National Infrastructure Planning website

ENDS

Journalists wanting further information should contact the Planning

Inspectorate Press Office, on: 0303 444 5004 or 0303 444 5005 or email:

Press.office@planninginspectorate.gov.uk

Notes to editors:

The Planning Inspectorate, National Infrastructure Programme of Projects details the proposals which are anticipated to be submitted to the Planning Inspectorate as applications in the coming months. It can be viewed at https://infrastructure.planninginspectorate.gov.uk/




Lord Pickles appointed as Advisory Committee on Business Appointments Chair

Lord Pickles appointed as Chair of the Advisory Committee on Business Appointments, from April 2020

Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office Michael Gove has today confirmed that Lord (Eric) Pickles has been appointed as Chair of the Advisory Committee on Business Appointments (ACOBA). He will take up the role on 1 April 2020.

The Chair is appointed for a five-year non-renewable term and leads the committee which independently advises the government, former ministers, senior civil servants and other Crown servants on the rules around taking employment after leaving their roles.

Lord Pickles was subject to pre-appointment scrutiny by the Public Administration and Constitutional Affairs Committee on 17 March 2020. The Committee concluded that Lord Pickles was a suitable candidate and wished him success in his role.

The appointment follows a fair and open recruitment exercise carried out in line with the principles of the Governance Code of Practice on Public Appointments, published by HM Government and regulated by the Commissioner for Public Appointments.




Update following announcement on exams and grades

We welcome the further information and clarity the Department for Education has outlined today to award students a calculated grade for their GCSEs, AS and A levels this summer, and to provide an exam option for those that wish it as soon as is reasonably possible after schools reopen.

We are working tirelessly to support students affected by these unprecedented and difficult circumstances and to develop, quickly, a fair and consistent process. We know that schools and colleges urgently need to know what they will need to do, and when.

Work is already underway with exam boards and teachers’ representatives to develop our proposals and we will provide more detail in the coming days.




COVID-19: suspension of 2020 Clinical Excellence Awards competition

The Advisory Committee on Clinical Excellence Awards (ACCEA) is aware of the increasing impact of coronavirus (COVID-19) on all NHS staff.

We know that Royal Colleges, employers, ACCEA committee members and applicants are concerned about the time needed to apply for an award and for employers to sign them off, which may be at the expense of clinical priorities.

We have therefore suspended applications for the 2020 national Clinical Excellence Awards competition. There is now no need to complete an application or for employers to sign off those already submitted.

We will implement contingency plans for new applications. We will also ensure that those whose awards expire in April 2021 are not disadvantaged by being unable to submit a renewal application.

Any applications already drafted will be saved. The online form will remain available until 5pm on Tuesday 24 March so that applicants can download their work.

We will provide further details next week after discussions with ministers and ACCEA committees.