Regulatory News - April 2021

Keep up to date with regulatory news from around the world with the Cell and Gene Therapy Catapult regulatory newsletter.


Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Early Access to Medicines Scheme Continues Through Pandemic

The MHRA have published an announcement highlighting their commitment to speeding up access to innovative new medicines for patients via the Early Access to Medicines Scheme (EAMS). The EAMS provides patients with seriously debilitating or life-threatening conditions access to medicines that do not yet have a marketing authorisation where there is a clear unmet medical need. This scheme has remained active throughout the COVID-19 pandemic ensuring patients can still be offered new treatment options for their conditions.

To read the full announcement, including examples of medicines issued a positive EAMS scientific opinion, see here.


European Medicines Agency (EMA)

Clinical Trial Information System Reaches Major Milestone Towards Go-live and Application of the Clinical Trial Regulation

The EMA Management Board have announced that the EU Portal and Database, the key component of the Clinical Trial Information System (CTIS) for the Clinical Trial Regulation (CTR), is on track to go live by 31 January 2022.

Following an independent audit of the EU Portal and Database, it has been confirmed that the system meets the functional specifications developed by the EMA, in collaboration with the European Commission (EC) and Member States.

This is a significant step forward for the implementation of the CTR. Once satisfied that the CTIS meets conditions set by the CTR, the EC will publish a notice in the Official Journal of the European Union, six months from which the Regulation will apply and the CTIS will go live.

For further information, see here.


Food and Drug Administration (FDA)

FDA Releases Guidance on Remote Inspections for Oversight of Drug Facilities During COVID-19

The FDA has issued a guidance document describing the interactive and virtual tools the Agency are using to carry out remote inspections. The purpose of this new guidance is to provide further clarity to regulated facilities on how the FDA will conduct remote interactive evaluations during the COVID-19 pandemic.

The guidance for industry details how the FDA request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packaged, or held, for the duration of the pandemic.

See here for further information, the FDA guidance is available here.


International Council for Harmonisation (ICH)

ICH Release Draft Work-in-Progress Good Clinical Practice Guidance Update

The ICH have released an explanatory note containing details of the update to ICH E6(R2) Good Clinical Practice (GCP) Guideline, which is currently under development by the ICH E6(R3) Expert Working Group (EWG). The ICH Management Committee acknowledge the substantial impact of ICH E6(R2) across the industry, and have therefore made a draft, work-in-progress version of the update available to stakeholders to facilitate transparency.

The renovation of the guidance will set out principles to be aligned with the principles in ICH E8(R1) Revision of General Considerations for Clinical Studies, which includes a framework for designing quality into clinical trials, stakeholder engagement, trial design, proportionate trial management and a focus on factors critical to the quality of trials.

Public comments are not requested at this time, however once the updated guidance achieves Step 2 of the ICH guidance development process, public input will be invited.

To read the ICH explanatory note and draft ICH E6(R3) Principles, see here.