Event Information

Time: October 1, 2015 (Thursday)

Place: TRPMA Conference Room

In order to improve the quality of drug companies’ NDA submission and speed up the review process, TRPMA invited Mr Bo-Yu Wang, Director of the New Drug Division of the TFDA, to brief the audience on the common deficiencies in the administrative dossier of NDA submission. Those deficiencies include:

1. The common deficiencies in the applications of imported APIs include incomplete information of the Chinese product name, the names of raw materials, the submission of GMP certificates and CPPs, etc.

2. The common deficiencies in the applications of post-approval changes and license extension include:

(1) Typing or selling errors of manufacturer’s name or address.

(2) The lack of dissolution study report or BE data of APIs in the applications of changes of manufacturing places, or the discrepancy of API manufacturer between the application and the original approval.

(3) The failure to observe the regulations concerning post-approval changes of labelling and package inserts.

(4) The failure to submit the applications of license extension or license renew at least six months prior to license expiry date.

Mr Wang suggested that drug companies should establish an internal apprentice system so that senior staff can pass their experiences to junior staff. This will not only reduce the chances of deficiencies and resubmission, but also expedite the TFDA’s review process.