Patient safety is our top priority. Based on the ICH guidelines, the pharmacovigilance systems of international pharmaceutical companies, and the regulatory requirements of the NMPA, Chipscreen Biosciences has created an integrated multi-division pharmacovigilance system administered by a dedicated Pharmacovigilance Department.
This department is responsible for monitoring, evaluating, and managing safety risks during the entire product life cycle, from first-in-human trials to clinical development and further to post-marketing safety assurance. To ensure drug safety, the department is also responsible for communicating with regulatory authorities and filing reports in accordance with regulatory requirements. We have also developed a series of SOPs and initiated regular training for all employees, requiring them to report any issues related to drug safety or quality promptly.
In March 2015, two campaigns - “Chidamide (Epidaza®) Charitable Donation” and “Chidamide (Epidaza®) Free Follow-up Medication” - were launched to improve medication accessibility. Since then, We have assistedover 5000 patients and donated over 70000 boxes of drugs, reducing the financial burden on patients and their families while extending life and improving quality of life.
Website for the Epidaza® donation campaign：http://www.aipusha.com/charit-89.html