•Publication Date：03/11/2014
•Source： Taiwan Today
Enhancing the management of generic drugs and ensuring the safety and well-being of consumers in Taiwan are key policy goals of the ROC government, according to the Food and Drug Administration under the Ministry of Health and Welfare March 10.
A control mechanism is in place to make sure Taiwan’s generic drugs are produced in line with international standards, the FDA said, adding that under the system, pharmaceutical companies must go through a rigorous quality control process before and after product launch.
In 2013, Taiwan implemented the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme—an international certification for promoting good manufacturing practice and pharmaceutical inspection, advancing to risk management-oriented quality control on generic medicine. This move underscores the government’s determination to maximize drug management and boost public health, the FDA said.
A set of monitoring and evaluation procedures to safeguard against poor-quality generic drugs post-launch has also been established, the administration said. Other initiatives include random checks of pharmaceutical-makers and products, as well as encouraging the public to report quality complaints.
The FDA said no untoward findings related to local generic drugs have surfaced over the past three years.
Future efforts to enhance the quality of generic drugs in Taiwan include implementing the Drug Master File system for active pharmaceutical ingredients, Good Review Practice, Good Pharmacovigilance Practice and improving regulations on excipient substances.
