DDReg Pharma

Pharmacovigilance Services in China

China ranks second worldwide in terms of its pharmaceutical market. It has undergone various changes concerning pharmacovigilance including structural, organizational, and evaluation and reporting methods with increasing public access to the healthcare system. The year 2021 marked a new beginning for China’s pharmacovigilance system with the introduction of “Good Pharmacovigilance Practices” (GVP). This was mainly intended to standardize and guide the role and responsibilities of marketing authorization holders in pharmacovigilance. According to the GVP guidelines, pharmaceutical companies must conduct a comprehensive drug safety evaluation to promote public health by reducing drug-related risks. The National Medical product administration (NMPA) of China oversees the safety of drugs including traditional Chinese medicine, ethnomedicine, medical devices, and cosmetics.
As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for China, we provide end to end pharmacovigilance services that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg Pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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