After triage, the case may enter the processing step. The purpose of case processing is to ensure a standard and structured way to capture the case information in the safety database.

In my last article in December 2016, I introduced about the pharmacovigilance system to be set up by pharmaceutical companies and one of the key elements being a quality system describing the procedures.

In my last article in October 2016, I used an example to discuss whether efficacy or safety comes first in the aspect of drug development. I would like to share Shyam Krishnan’s response, which well summarizes that pharmaceutical...

橘皮書(The Orange Book)是由美國食品藥物管理局FDA官方出版的書冊，正式名稱為「具治療等效性評估之核准藥品目錄(Approved Drug Products with Therapeutic Equivalences)」，登錄包含經FDA核准上市藥品之專利資訊...

資料專屬權(Data Exclusivity )是指原廠(第一個新藥開發廠)提出新藥上市申請時，所檢具證明安全性及療效之各種相關申請資料，其他藥商非經原廠同意，於法定之保護期間內不得引用，簡而言之，就是行政機關針對原廠新藥上市申請資料給予的行政保護權。