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Highlights of 2019

Ensuring the safety, effectiveness and quality of drugs is the unanimous goal among all employees of PharmaEssentia. In all stages of the value chain, PharmaEssentia follows the relevant regulations of the competent authorities of different countries, the pharmaceutical industry, as well as around 4,000 internal standard operating procedures (SOPs) and various plans and reports. Starting from preclinical studies, we follow the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) for drug research, then move into the clinical trials. We conducted in accordance with the GCP to protect the rights, safety, and well-being of subjects, this is our most important goal at this stage. In manufacturing phase, we follow the GMP; at the time of distribution and supply, we follow the requirements of the GMP and GDP as well. As for the safety monitoring of post-marketing drugs, we follow the Good Pharmavigilance Practice (hereinafter referred to as GVP). Considering the limitations of safety data in clinical trials and safety issues arising from the widely use of the marketed drug, PharmaEssentia has established a pharmacovigilance function at the headquarters to integrate safety information of Ropeginterferon alfa-2b (P1101). In addition, we set up a global pharmacovigilance & reporting system among strategic partners and subsidiaries to react immediately and to reduce harm. We are devoted to monitoring illegal medicine by recall procedure and traceability management. Furthermore, we ensure that patients receive the medicine with proper usage by medical health education and prevention procedures. We demand of ourselves to meet the toughest safety standards and minimize any harms or defects to make sure the product we provide is safe and effective. Trust is the foundation of strong business relationships, PharmaEssentia is a trustworthy enterprise and we are eager to become a top multinational pharmaceutical company with social influence.

Ensuring the quality and safety of drugs
Excellent manufacturing and production
Drug storage and transportation
Patient safety monitoring
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2019 CSR Report