Regulatory News - December 2020

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Publish Further Post-Transition Guidance

The MHRA continue to provide updated guidance on the lead up to the end of the Brexit transition period.

Updates this month include:

• Guidance on submitting clinical trial safety reports from 1 January 2021;
• Guidance on MAH and QPPV location from 1 January 2021;
• Supplying investigational medicinal products to Northern Ireland.

See here for further information and up-to-date post-transition guidance on the MHRA website.

Human Tissue Authority (HTA)

HTA Licence Fees 2021/2022

The HTA have published their licence fee levels for the business year 2021/2022.

There have been no changes to the licence fees for the coming year to ensure there is no additional burden or financial pressure on HTA establishments.

See here for the announcement and full details of HTA licence fees.

EU

European Medicines Agency (EMA)

Revised Guideline on Quality, Non-clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells

The EMA has published a revised version of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, which will be effective from 1^st June 2021.

The revision captures recent developments and experience gained in the area of genetically modified cells since the first version of the guideline was published (3^rd May 2012). The Agency has since approved the first gene therapy medicinal product based on genetically modified cells.

A summary of the updates is provided below:

• Quality section:

Guidance updated in line with the evolution of science and regulatory experience, focussing on starting materials, comparability and validation.

• Non-clinical section:

Updates incorporate current thinking on the requirements to conduct non-clinical studies.

A section discussing scientific principles and guidance for CAR-T cell and TCR products, induced pluripotent stem cell derived cell-based products and cell-based products derived from genome editing is included.

• Clinical section:

Recent experience with scientific advice and MAA procedures has been captured, and an annex on CAR-T specific clinical aspects included.

To read the updated guideline, see here.

Public Consultations

EUROPEAN MEDICINES AGENCY (EMA)