On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation).
The purpose of the pTAP, which will apply to drug products that follow the Canadian Drug Agency’s (formerly Canadian Agency for Drugs and Technologies in Health (CADTH)) time-limited reimbursement recommendation pathway, is to allow patients temporary access to drugs with promising early results while further clinical evidence is collected. Full details of the program are available on the pTAP webpage. pTAP is a pilot project and will be subject to regular monitoring and assessment. Currently, there is one drug that is in active pTAP negotiation, EPKINLY (epcoritamab).
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.