China Releases Guidelines for Preparing Pharmacovigilance Outsourcing Agreement (Interim)

4 June 2020, The China National Centre for Adverse Drug Reaction (ADR) Monitoring releases guidelines applicable for drug marketing license holders (hereinafter referred to as “holders”) who carry out pharmacovigilance work.

The aim of the document is to clarify and standardize the responsibilities of the holders and trustees in the commissioning of pharmacovigilance in ensuring identification, monitoring, evaluation and control of post marketing adverse drug reactions and other drug-related harmful reactions.

The guidelines will assist the holders when preparing pharmacovigilance commission agreement.

In the event a trustee is entrusted to carry out pharmacovigilance work, the legal responsibility lies on the borneholder. For example, if the holder is an overseas enterprise, the  trustee entrusted by it within the territory of China shall perform the obligations of the drug marketing license holder and bear joint and several liabilities with the drug marketing license holder.

The scope of the guideline includes preparation of the agreement including pharmacovigilance entrusted matters such as adverse drug reactions and serious adverse drug reactions occurring overseas and the requirements in selecting a trustee.

The holder and the trustee’s relevant person are parties to the agreement and relevant responsible departments participate in the drafting and formulation of the pharmacovigilance commission agreement.

Audit, data, and risk management procedures are also incorporated as requirements in the guideline.
It is provided in the guideline that the holder and the trustee shall establish a good and effective communication mechanism and formulate a communication plan.

Please refer to the link below for further information:-

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