Adalvo is delighted to announce that our partner, 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. SME Designation has allowed for improved success rate for organizations seeking regulatory approvals:
- 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; half of these target a rare disease.
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This exciting collaboration further paves the road to Adalvo’s differentiated capabilities and our ability to commercialize an array of innovative, high value products.
For further information, please contact Margarida Neves at margarida.neves@adalvo.com