Regulatory News - November 2020

UK

Department of Health and Social Care (DHSC)

Quality and Safety of Human Organs, Tissues and Cells from 1 January 2021

As part of the Government’s ‘Brexit transition, new rules for 20210’ suite of guidance, the DHSC have released information for hospitals and tissue establishments on ensuring the quality and safety of human organs, tissues and cells post-Brexit transition period.

From 1^st January 2021, establishments intending to import or export human tissues and cells for human application will need to treat suppliers within the European Economic Area (EEA) as third country suppliers.

Tissue establishments in Northern Ireland will need to treat suppliers in Great Britain in accordance with the relevant EU regulations on non-EU suppliers. Therefore if an establishment in Northern Ireland received tissues or cells from Great Britain, they will need to ensure they have an import licence as well as an import agreement in place with the supplier.

The guidance also provides an update on the process for ensuring traceability of tissues and cells. Tissue establishments in Great Britain will no longer need to use the Single European Code (SEC), unless they wish to do so, and traceability systems used prior to the implementation of the SEC can be used.

To read the full guidance, see here. Further information for tissue establishments is now available on the HTA website, see below.

Human Tissue Authority (HTA)

HTA Release UK Transition Guidance

The HTA have released guidance on their website explaining how regulatory changes within the UK at the end of the transition period will impact on HTA licence holders.

HTA-licensed establishments will need to prepare for the end of the transition period; establishments licenced under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 will not require changes to their licence after the end of the transition period. However, establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) may require changes depending on the activities the licence holder intends to carry out.

Establishments intending to import tissues or cells from EU countries, or export tissues and cells to countries within the EU for human application, may need to vary their licence in order to continue these activities post-transition. This includes HTA-licenced establishments who intend to import or export cells and tissues as starting material for the manufacture of Advanced Therapy Medicinal Products.

There will be a six-month phase from 1^st January 2021 to allow time for establishments to comply with new licensing requirements, but the HTA have set out the steps that can be taken in advance to prepare for this.

The full guidance is available here.

US

Food and Drug Administration (FDA)

FDA Online Orphan Drug Designation Submission Portal

The FDA has launched a new cloud-based submissions portal for orphan drug designation requests, allowing electronic submissions. This new portal is part of the agency’s orphan drug technology modernisation effort, moving away from the current paper and CD-based submission process.

In addition to the new submissions portal, the FDA has implemented a new internal system; the orphan drug designation workflow management tool, which proposes to increase the efficiency of reviews.

For further information and to access the portal, see here.

International

World Health Organisation (WHO)

WHO Public Consultation: GMP for Investigational Products

The WHO has released and updated draft document guidance to industry on good manufacturing practices (GMP) for investigational medicinal products (IMP), including new recommendations for quality risk management. The objective of the update is to bring the guideline in line with current expectations for trends in GMP and to harmonise text with the principles from other international guidance.

The draft guideline was released in November 2020 and is open for public consultation until 6^th January 2021.

The draft guidance and information on responding to the public consultation is available here and table for comment is available here.

Public Consultations

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)

EUROPEAN MEDICINES AGENCY (EMA)

WORLD HEALTH ORGANISATION (WHO)