Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) are a complex and diverse group of medicinal products, covering tissue engineering products, somatic cell therapies and gene therapies.

Although ATMPs are medicinal products, and therefore covered by all standard regulatory requirements for medicines in the EU, they are also subject to specific procedures and guidelines applicable to ATMPs only. The developer needs a detailed appreciation of these aspects of the EU regulatory framework. This field is evolving rapidly, and interpretation of the guidance to match the regulators' developing expectations is a critical component of successful advanced therapy development.

Advanced therapies are a large part of the regenerative medicine landscape, but other approaches including novel biomaterials and human tissue products are in development especially for tissue engineering/tissue regeneration applications. Early and correct classification advice is essential to ensure the right regulatory route is chosen: the entire business case for the product depends on this.

 

EU Services

We offer regulatory affairs input and guidance on key regulatory procedures and aspects of ATMP development:

  • ATMP classification advice  and EMA procedure
  • EMA Innovation Task Force meetings
  • EMA Scientific Advice meetings
  • National Competent Authority scientific advice meetings
  • EMA Classification Procedures
  • Clinical Trial Authorisations
  • Risk-Based Approach to development of ATMPs
  • Compliance with EU Directive 2004/23/EC on safety and quality of human tissues and cells

We can provide full support for development of advanced therapies, including:

  • Advice on product classification: ATMP or not? What type of ATMP?
  • Strategic plannng and development roadmaps
  • Preparation of clinical trial applications, briefing packages, gap analyses of existing data
  • Module 2 and 3 data summaries and document writing

 

US Developments

  • Gap analysis against EU data requirements at any stage in product development
  • Cell and gene therapies and tissue engineering products developed in the US under CBER regulations are likely to be supported by a similar range of data to that expected for ATMPs in the EU. However there are differences in approach between the regions that will need to be addressed before a US data package meets EU expectations. We can assess IND submissions against CTA requirements to facilitate rapid approvals for entry into EU clinical trials.

Recent Projects

Allogeneic MSC for tissue engineering

CellData Services is developing a long-standing collaboration with a UK-based regenerative medicine company, providing regulatory affairs support and expert guidance on a long-term basis. The company is adapting their core tissue engineering technology from autologous to allogeneic cells. This is a...

Read case study | All ATMPs case studies

EMA Scientific Advice for US-based somatic cell therapy

CellData Services was asked to provide a detailed assessment of the data available on a US-based somatic cell therapy for neurological disorders. As this product was at a quite advanced stage in its development for the US market, it was important for the client to gain an understandin...

Read case study | All ATMPs case studies