CellResearch Corporation (CRC) has been awarded SME Designation by the European Medicines Agency (EMA)
The success rate for SME marketing authorisation applications for human medicines more than doubled, reaching 89% in 2020;
More than 4 in 10 medicines selected for EMA’s PRIME: priority medicines scheme were from SMEs;
SMEs developed nearly 20% of all human medicines recommended for authorisation in 2020
Singapore, 16 February: CellResearch Corporation (CRC), a clinical stage company developing innovative stem cell therapies, announced today that the European Commission and the European Medicines Agency (EMA) has granted CRC the SME designation (SME).
The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information and training from dedicated EMA personnel during the clinical development process. Companies with this designation engage in early dialogue with the EMA multidisciplinary team and discuss regulatory strategy with the goal of mitigating delay and accelerating patient access to lifesaving treatments.
In addition, SME designation gives companies reduced administrative fees throughout the development process.
Gavin Tan, CEO of CellResearch Corporation said of the award “ This is a welcome decision by the EMA. It will allow us to more smoothly navigate the regulatory approvals process in Europe and hopefully accelerate patient access to our therapeutic platform”
About CellResearch Corporation
CellResearch Corporation(CRC) was founded in Singapore in 2002.It’s original remit was to provide skin and scar cells to laboratories around the world for research. In 2004, CRC scientists isolated Epithelial and Mesenchymal Stem Cells from the Umbilical Cord Lining Membrane. This novel and significant discovery was put up for intellectual property protection, and CRC now holds a portfolio of patents surrounding this discovery.
The umbilical cord lining membrane is now known to be the richest source of stem cells in the body, and both epithelial and mesenchymal stem cells are being researched intensively with collaborators all around the world to exploit their potential for downstream medical therapy.
CRC’s first therapeutic asset: CorLiCyte® is indicated for the treatment of Chronic Diabetic foot ulcers. It is in the latter stages of a Phase 1 trial in the US in partnership with the University of Colorado Anschutz medical campus. This technology has recently been award ILAP designation by the UK Health authority (MHRA) as a potentially innovative medicine.
CRC has been able to leverage this knowledge to produce a ground breaking cosmeceutical line called CALECIM® which has anti-aging benefits when applied topically to the skin.
It is available online at: calecimprofessional.com and in the best aesthetic clinics around the world.
Enquiries should be directed to:
Xavier Simpson (Associate Director, Business Development + Investor Relations)
E-mail: xaviersimpson@cellresearchcorporation.com