Event Information

Time: June 8, 2015 (Monday)

Place: RPMA Conference Room

TRPMA once again invited Dr Min Chen, a former official of the US FDA, to give a lecture on risk management.

Dr Chen pointed out that the first step of managing drug risk is to properly label a drug product according to its risk profile. The labelling (whose contents include adverse reactions, contraindications, warnings, precautions, etc.) should be able to provide doctors with complete, clear and sufficient drug safety related information so as to ensure medication safety. The second step is to decide whether it is necessary to implement risk management measures such as post-marketing surveillance.

After comparing the risk management regulations in the US and the EU, Dr Chen found out that the current Drug Risk Management Guideline implemented in Taiwan is based on the Risk Evaluation Mitigation Strategy (REMS) formulated by the US FDA. The Guideline requires drug companies to prepare: 1. medication guide (MG), 2. communication plan (CP), 3. element to assure safety use (ETASU). According to the information from the US FDA, 41 new drugs were approved by the US FDA in 2014. Among them, 11 items are subject to REMS, including 7 cases of CP, 3 cases of ETASU and CP and 1 case of MG.

Generally speaking, drug risk management plan aims to reduce the drug risk posed to patients. It is important that drug manufacturers start collecting and analysing relevant information as early as in the R&D stage.