Regulatory News - August 2021

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

Early Access to Medicines Scheme (EAMS) Consultation

The MHRA have released a consultation on proposed legislative changes to clarify the legal basis for EAMS. Currently there is no UK legislation specific to EAMS, and the scheme is non-statutory. This proposal introduces legislative changes which are designed so that EAMS remains relevant following the UK’s exit from the EU. It also aims to ensure the scheme is an attractive option for patients, healthcare professionals and companies, so that cutting-edge therapies are available for patients where there is an unmet clinical need. The proposals also support the UK life sciences agenda in making the UK an attractive place to bring innovative products.

The MHRA have requested feedback on the proposed changes and the consultation is open until 17^th September 2021.

To read the full article, see here. The consultation document is available here.

MHRA Point of Care Consultation

The MHRA have released a public consultation detailing a proposed regulatory framework for Point of Care (POC) manufacturing. POC manufacturing denotes the manufacture of personalised medicines for patients that are either within, or very close to the location they receive medical care.

POC products, including some types of ATMPs, tend to have a short shelf life in the order of hours, minutes or less, which impacts the range of options for manufacture of these products. Products need to be manufactured within very close proximity to the patient as there is only time for local supply of the product, meaning large scale manufacture is not possible and there is often the requirement for a large number of manufacturing sites. It is also likely that there will not be time at the end of manufacture for Quality Control testing and Qualified Person release, meaning that the control measures in place during manufacture are required to provide assurance of product quality for supply.

With this proposed POC framework, the MHRA aim to support increased manufacture of such products whilst ensuring the same assurance of safety, quality and efficacy as is currently in place for more conventional medicinal products. The consultation is open for six weeks from the 12^th August 2021 to 23^rd September 2021.

For further details on the POC consultation see here. The consultation document is available here.

EU

European Medicines Agency (EMA)

EMA Release Guideline on Labelling Requirements for ATMPs Containing Genetically Modified Cells

The EMA have released a draft guideline on the summary of product characteristic (SmPC), labelling and package leaflet for ATMPs containing genetically modified cells, detailing the information expected to be included in these documents. The guideline is applicable to allogeneic and autologous cells genetically modified through methods such as genome editing and viral vectors (CAR-T cells and CD34+ modified cells are given as example product types).

The draft guidance has been released for public consultation, and the EMA are accepting feedback until the 31^st October 2021.

The draft guideline is available here. For information on the consultation, see here.

European Commission (EC)

Launch of Clinical Trials Information System (CTIS) Confirmed

The EC have published its decision notice in the Official Journal of the European Union, confirming the EU Portal and Database (a key component of the CTIS) has reached full functionality and is in compliance with the Clinical Trials Regulation (EU) No 536/2014 (CTR). As set out in the CTR, the publication of this notice confirms the entry into application of the Regulation and go-live of the CTIS will be on 31^st January 2022 (six months from the publication of the notice).

Under the CTR, the use of the CTIS is mandatory for all new clinical trial authorisation applications. However, there will be a three-year transition period in place whereby applicants have the option to submit their application in line with the current system (following the Clinical Trials Directive), or according to the CTR until 31^st January 2023. From this point onwards, it will become mandatory for all new submissions to comply with the CTR. All ongoing clinical trials approved under the Clinical Trials Directive must transition to the CTR and CTIS by 31^st January 2025.

To read the full press release, see here. Further information on the CTIS is available on the EMA website, here.

INTERNATIONAL

World Health Organisation (WHO)

WHO Release Revised Good Manufacturing Practice (GMP) Guidance for Investigational Products

WHO has released a draft revised guidance for industry on GMP for investigational medicinal products. The guidance has been updated to align with current expectations and harmonise the text with principles from other related international guidelines.

The guidance addresses a wide range of GMP related issues including quality management, quality risk management and issues relating to manufacturing premises, equipment and utilities.

See here for the draft guidance.

Public Consultations

MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)

EUROPEAN MEDICINES AGENCY (EMA)