Advanced Therapy Medicinal Product (ATMP)
An advanced therapy medicinal product (ATMP) is a medicinal product based on genes, tissues or cells, offering ground-breaking treatment opportunities.
ATMPs can be classified into three main types :
- Gene therapy medicinal product
- Somatic cell therapy medicinal product
- Tissue engineered medicinal product
Some ATMPs are referred to as “combined ATMPs”: they contain one or more medical devices as an integral part of the medicine.
Authorization Process for Advanced Therapies
All advanced therapies are authorized centrally via the European Medicines Agency (EMA) and benefit from a single evaluation and authorization procedure
The criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007. EMA’s Committee for Advanced Therapies (CAT) delivers scientific recommendations on ATMP classification after consultation with the European Commission within 60 days after receipt of the request.
Sponsors requiring clarification as to whether their product is classified as an ATMP can receive confirmation from the committee for advanced therapies (CAT) prior to submitting any application to the Agency. This advice is provided free of charge within 60 days of receipt of a valid request from an applicant.
BlueReg can guide you through this complex area to submit a classification application to CAT to determine if your product meets the requirements to be defined as an ATMP. Our team can also support you through the entire application process from development, to registration and post-approval management.
Early Access Programmes (ATU)
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs (ATU) projects (nominative and cohort) in France .
Scientific Advice & Interaction with Health authorities
BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.
CMC Product Development
Looking for Chemistry, Manufacturing & Controls (CMC) expertise ? BlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.
Clinical Trial Applications (CTA)
Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organization significant time and money.
Drug Development Consulting & Strategy
Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond. We can provide advice and recommendations to ensure the shortest time to market by minimizing any possible barriers during the development process and beyond.
Orphan Drug Designations (ODDs)
Looking to apply for ODD designations ? BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your EMA/FDA application.
Pediatric Investigation Plans (PIPs)
BlueReg can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US.
EMA/HTA Parallel scientific advice
Looking for support with your EMA / HTA bodies Parallel Consultation? BlueReg can provide a team of highly experienced consultants specialized in regulatory affairs, market access and scientific writing. Our consultants can advise you on all steps of the procedure and author the required documents required for this important process.
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