Regulatory news - June 2020

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

EU

European Commission (EC)

EC Propose to Relax GMO Regulations for COVID-19 Vaccines

The EC have released a proposal to adjust the EU legislation on handling of genetically modified organisms (GMO) to relax requirements for vaccines under development for the virus responsible for the coronavirus pandemic, SARS-CoV-2.

Currently, the EU GMO legislation includes two Directives; 2001/18/EC on the deliberate release of GMOs into the environment, and 2009/41/EC on the contained use of genetically modified microorganisms. EU member states differ in the implementation of these directives, with varying approaches to the assessment of GMO aspects of clinical trials. The EC have released the proposal in order to adapt the regulatory framework on GMOs so that the conduct of clinical trials with potential vaccines containing or consisting of GMOs can start within the shortest possible timelines, while ensuring the rights, safety, dignity and well-being of those individuals that take part in a clinical trial, as well as the reliability and robustness of the data generated and adequate protection of the environment and of human health via the environment.

The derogation would allow potential vaccine candidates that contain or consist of GMOs to proceed with clinical trials within shorter timelines and without a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC while COVID-19 is declared as a pandemic.

To read the full proposal, see here.

 

EC Launch Public Consultation on EU Pharmaceutical Strategy

The EC have opened an online public consultation on the Pharmaceutical Strategy for Europe. The consultation has been launched in light of the COVID-19 pandemic and will focus on key themes including strategic autonomy and manufacturing of medicines, access to affordable medicines, innovation and lessons learned from COVID-19 on how to better prepare for future pandemics.

The public consultation feedback period will last from 16th June to 15th September 2020.

For full details of the public consultation, see here.

 

European Medicines Agency (EMA)

EMA Offers Free Scientific Advice to Academia for Orphan Drug Development

The EMA have announced they will waive all scientific advice fees for academia developing orphan medicines. Academia play an important role in the development of innovative medicines and early interactions with EU regulators is key for effective navigation of the regulatory process. This fee incentive has been introduced in light of feedback from academia showing that fees for protocol assistance present a significant hurdle for development.

For more information, see here.

 

EMA Update on Clinical Trials Regulation Go-Live Plan

One of the highlights from the EMA Management Board virtual meeting, held on 11th June 2020, was an update on the progress of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation (CTR). The Board have endorsed the next steps of the CTIS ‘go-live’ plan, which proposes to fix the go-live date to December 2021.

The scope has been finalised for the upcoming CTIS audit due to start in December 2020 and the EMA Board will be monitoring key performance indicators and delivery of the items selected for audit ahead of the proposed go-live date.

For further information, see here.

 

 

INTERNATIONAL

USA

US Food and Drug Administration (FDA)

FDA Update on COVID-19 Impact for Cell and Gene Therapies

The FDA provided an update on the impact the coronavirus pandemic has had on the Agency’s work related to cell and gene therapies at the BIO Digital Convention. Wilson Bryan, Director of the Office of Tissues and Advanced Therapies at the Center for Biologics Evaluation and Research (CBER), spoke at the session on cell and gene therapies on Monday 8th June.

He highlighted that CBER have been busy with an increase in interest in using cell therapies and intravenous immunoglobulin to treat COVID-19 and, as with other offices at the FDA, work related to the pandemic is being prioritised. As a result, industry can expect some delays in terms of responses, meetings and new guidance.

For further information, see here.

 

Public Consultations

EUROPEAN COMMISSION (EC)

 

Title

Consultation

Period

Category

1

Pharmaceuticals – safe and affordable medicines (new EU strategy)

16 Jun 2020

To

15 Sep 2020

Public Consultation

 

FOOD AND DRUG ADMINISTRATION (FDA)

 

Title

Consultation

Period

Category

1

Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

28 Jan 2020

To

28 Jul 2020

Draft Guidance

 

Discover who we are