Taiwan’s Plans to Adopt International Guidelines for Drug Manufacturers

Taiwan’s Department of Health (DOH) has mandated that local drug manufacturers comply with the “Guideline for International Standard Site Inspection,” based on the Pharmaceutical Inspection Cooperation Theme (PIC/S). As of now, the DOH has sent requests to over 160 local drug manufacturers to comply with the new requirement.

To comply with PIC/S, manufacturers will need to produce certain drugs in dedicated facilities to avoid cross-contamination. These drugs include antibiotics, hormones, and anti-cancer drugs. Local manufacturers must comply with these requirements by 2009. Those companies who fail to do so may not get their licenses renewed by the DOH.

Currently for drug registration in Taiwan, applicants must submit a detailed Plant Master File before submitting the actual dossier. However, if Taiwan becomes an official member of PIC/S, the DOH will allow a Site Master File plus a PIC/S inspection report to fulfill this requirement. As of now, Taiwan has been unsuccessful in becoming a signatory to PIC/S.