Implementation of e-submission of the Registration and Market Approval of Pharmaceuticals and “Common Technical Document (CTD)” Format

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Implementation of e-submission of the Registration and Market Approval of Pharmaceuticals and “Common Technical Document (CTD)” Format Helps Enhance the Document Quality of the Registration and Market Approval of Pharmaceuticals and the Review Performance in Our Nation

In order to enhance the document quality of the registration and market approval of pharmaceuticals and the performance of review operations, as well as to promote the export of pharmaceuticals produced by domestic pharmaceutical industry, to match the document quality of application for export with that of international standards, to reduce application difficulties and to be environmentally friendly through reducing energy use and carbon footprint, the Food and Drug Administration (FDA) announced, on July 24, 2012, the availability of the “Common Technical Document (CTD) format” and requests that starting from November 1, 2012, manufacturers should fill in required information for application for registration and market approval of pharmaceuticals for new chemical entity (NCE) using CTD format and submit it using e-submission.

Our CTD format utilized the Common Technical Document (CTD) formulated by the International Conference on Harmonisation (ICH) in the United States, Europe and Japan as a reference. To promote the harmonisation of the registration and market approval of pharmaceuticals between different countries in the international community, the ICH specifies the CTD format used for submitting documentation of the registration and market approval of pharmaceuticals to accelerate the efficiency of the review operations of the registration and market approval of pharmaceuticals between countries and to assist pharmaceutical companies in reducing the cost, labor and time spent in preparing documentations for new drug application (NDA) to other countries, so as to speed up market approval of pharmaceuticals to enable patients to have access to new drugs timely.

Starting from November 1, 2012, the registration and market approval of pharmaceuticals for NCE should follow the “Common Technical Document” format announcement. Moreover, starting from October 15, the application for registration and market approval of pharmaceuticals can be submitted to FDA electronically. Encrypted DVD following the FDA-announced “CTD format” enables instant search of documents needed during the review process, which enhances the performance of drug reviews.

It is expected that the implementation of e-submission of the registration and market approval of pharmaceuticals and “Common Technical Document” format can enhance the performance of review operations of our registration and market approval of pharmaceuticals, thus enabling our citizens to use the safe and effective new drugs developed by the international community, and promoting our pharmaceutical export development, public interest and health.