Event Information

Introduction
Summary

Time：April 20, 2015 (Monday)
Place：TRPMA Conference Room

The 2015 communication meeting between the Division of Medicinal Products of the TFDA and pharmaceutical associations was chaired by Ms. Li-Ling Liu of the TFDA. The head of each division reported current divisional businesses (please refer to the attachment for discussions in the meeting.) The key points are summarized as follows:

Changes of package inserts to list all excipients should be completed before Dec. 31, 2015. Application fees are exempt.
In order to increase the review efficiency of IND submissions, TFDA will focus its review on safety. It is the applicant’s responsibility to ensure that the trial design and results meet the NDA requirements. Any quires can be made to the CDE Advisory Service. From Feb. 4, 2015, applicants of medicinal products or regenerative medicine products can apply to sit in the review meeting and explain the rationale behind the trial design to the reviewers in order to enhance their understanding of the case.
Ms. Shu-Ing Cheng, Secretary General of the Regulatory Affair Professional Society (RAPS), Taiwan, briefed the audience on the Regulatory Affair Certificate (RAC) system. Please refer to the attachment for details.
Taiwan Society of Health System Pharmacists introduced the international guidelines on the management of toxic drugs in non-safety packaging. The TFDA plans to draft similar guidelines to reduce the risk of exposing clinical practitioners to toxic drugs.
TFDA will subject drugs not under surveillance to retrospective BA/BE tests. Drug companies can apply for exemption based on self-assessment results. The criteria for exemption are not yet decided. Comments or suggestions can be made to TRPMA before May 8 (please email to [email protected].tw). TRPMA will collate opinions and forward them to TFDA.
There will be further discussions on the regulations concerning inner packaging stated in the “Guidelines on labelling international product code on every layer of packaging of prescription drugs in Taiwan (Draft)”.