Taiwan Food and Drug Administration (TFDA) recently announced several new policies and partial amendment of procedures for drug registration and approval, consultant service, to speed up the drug review process and improve the quality and efficiency of approval system for medicinal products. The new policies and major amendments are listed as follows:

1. Partial amendment of expedited review system and new drug review path

Accelerated approval pathway, priority review designation and abbreviated review designation are programs of TFDA which intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

The new qualifying criteria of accelerated approval, priority review and abbreviated review are as follows:

Accelerated Approval (all criteria need to be met)

• New chemical entities, new combination, new indication and new administration route.
• An application for a drug which addresses unmet medical need in the treatment of serious conditions and providing major clinical advance. OR

An application for a drug which addresses unmet medical need with orphan drug designation in advanced countries.

• An application that demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

Priority Review (meet two of the following criteria)

• New chemical entities, new combination, new indication and new administration route.
• An application for a drug which addresses unmet medical need in the treatment of serious conditions and, if approved, would provide major clinical advance.
• An application for a drug which addresses unmet medical need and is under special national scientific research and development programs.

Abbreviated Review

An application for new chemical entities which fulfills all the following criteria:

• Approval by two of the three regulatory agencies (US FDA, EMA, or MHLW/PMDA) and with bridging study waiver.
• Providing full review reports from two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).
• Providing Risk Management Plans and updated Post-marketing Commitment reports requested by two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).

By comparison, the first criterion for accelerated approval pathway and priority review designation was amended from “new chemical entities only” to a broader range as “new chemical entities, new combination, new indication and new administration route”. For abbreviated review designation, the “MHLW/PMDA” was added as one of the reference regulatory agencies.

2. Announcement of review milestones timelines

In order to improve the transparency of review process, TFDA announced detailed review milestones timelines for NDA/BLA as illustrated in Figure 1. This would benefit the preparation of NDA/BLA submission.

3. Refusal to File (RTF) procedures for NDA/BLA and ANDA

RTF is a new policy to facilitate TFDA/CDE processes by avoiding unnecessary review of incomplete applications. It is applicants’ obligation to provide complete packages for TFDA/CDE to initiate appropriate review processes. From 2017, applications which are not prepared in CTD format or without complete administrative or technique documents are subject to RTF decisions.

The RTF procedure is illustrated in Figure 2.

4. New policy of consultation service

Huge investments are required, including time and resource, to develop a new drug. Pre-NDA Meeting, Pre-ANDA Meeting and Module-Based Rolling Review are new consultation services initiated by TFDA/CDE to accelerate and encourage the new drug development in Taiwan. These new fee-charging services are described below:

Pre-NDA Meeting, Pre-ANDA Meeting

Under preparing for new drug application and generic drug application, sponsors might be interested in the basic requirements or TFDA/CDE review processes. The purpose of the Pre-NDA or Pre-ANDA Meeting is to discuss filing and format (CTD format) issues prior to NDA/ANDA submissions. The meeting also addresses issues that may cause refuse-to-file or hinder the review process. TFDA/CDE can also be aware of upcoming applications and equipped with required resources.

Module-Based Rolling Review

Module-Based Rolling Review is another consultation service especially for those cases have been enrolled in TFDA counseling projects and CDE index cases list, which allowing earlier submission and initiation of review. Sponsors can submit completed sections of its NDA or BLA in CTD format for TFDA/CDE’s review, rather than waiting till all sections of the NDA/BLA are completed.

With the aforementioned amendments, the quality and efficiency of drug approval process are expected to be significantly improved and will lead to a better development of new drug industry in Taiwan.