CannPal Granted SME Status by the European Medicines Agency (EMA)
- CannPal has received confirmation of SME (Small and Medium size Enterprises) status,with the European Medicines Agency (EMA)
- The European Medicines Agency is the European Union agency responsible for the evaluation and regulation of veterinary medicinal products (VMP’s) in Europe;
- The SME status allows CannPal a line of communication with the EMA for the development of its cannabis derived veterinary medicines in Europe;
- CannPal is now eligible to benefit from administrative and financial assistance with the EMA for the development of its drug products for European approval.
Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) (“CannPal” or “the Company”) is pleased to announce it has been granted SME status by the European Medicines Agency (EMA), having received confirmation of the eligibility to benefit from the provisions for administrative and financial assistance for SME’s (Small and Medium size Enterprises) laid down in Regulation (EC) No 2049/2005.
The Company was granted SME status in collaboration with CannPal’s European regulatory research partner, Klifovet AG, one of Europe’s largest veterinary research organizations.
The SME Status will allow CannPal to benefit from administrative and financial assistance for the development of its drug products, which will be developed in parallel for both FDA (Food and Drug Administration) and EMA approvals. The SME status also opens a direct line of communication with the European Medicines Agency, and will provide CannPal with access to scientific support for the development of CPAT-01, the Company’s lead drug candidate.
CannPal’s Founder and Managing Director Layton Mills
“We are delighted to have received confirmation of CannPal’s SME status with the EMA.
The European Medicines Agency are known to set a gold standard for veterinary drug development, and the opportunity to access administrative, financial and scientific support from the agency will significantly aid in the development of our products for regulatory approval in the European Union.
The opportunity for parallel development in Northern America and Europe exposes the Company to a significantly larger market, with both regions collectively sharing in over 60% of the global companion animal drug market, estimated to be worth over $30b.
We’re looking forward to commencing the clinical phase of the development program for our lead drug candidate, CPAT-01, with our first studies commencing in CY Q1 2018.”