Event Information

Time：May 6, 2015 (Wednesday)
Place：TRPMA Conference Room

TRPMA invited Dr. Churn-shiouh Gau, the CEO of CDE, to talk about the key points and the trends of pharmacovigilance and risk management plan. Dr. Gau gave an insightful analysis from the viewpoint of the review agency.

Dr. Gau started her talk by introducing the background and origin of pharmacovigilance. It started after the tragedy of thalidomide in 1950-60 and sparked the introduction of the Yellow Card Scheme in the UK, the MedWatch in the US and the inauguration of the Collaborating Center for International Drug Monitoring in the WHO. These systems were established to collect reports of drug safety matters and to issue safety warnings so as to prevent health hazard to the public. Dr. Gau explained the three steps for the formulation of pharmacovigilance strategies: 1. to identify potential drug safety issues by establishing a voluntary reporting system; 2. to verify those safety issues by applying scientific methods; 3. to take appropriate measures to eliminate the safety issues. The pharmacovigilance strategies should be able to protect patients’ medication safety and to prolong the life cycle of drug products.

It has been a global trend to request manufacturers to submit the Risk Management Plan along with their NDA dossiers. The Risk Management Plan should contain drug safety data, pharmacovigilance plan and the plan to minimize the risk. Dr. Gau also analysed and compared the RMP implemented in the EU and the REMS implemented in the US. She reminded new drug developers to start planning the pharmacovigilance plan in Phase III so that the NDA schedule would not be affected.

According to the speech made by Dr. Min Chu Chen in March, about one-third of the new drugs approved by the US FDA in 2014 were subject to the REMS. It is foreseeable that risk management will become a key factor for drug review. The TRPMA will continue with this issue and held relevant seminars and speeches for our members.