TFDA eCTD Specification :
The Taiwan Food and Drug Administration (TFDA) has recently released its guidelines for the electronic Common Technical Document (eCTD) format, aiming to standardize and streamline drug application submissions.
Following the example of regulatory bodies like the FDA, EMA, and other international agencies, Taiwan is moving to adopt eCTD standards to enhance efficiency in reviewing and approving pharmaceutical products.
The TFDA’s guidelines, which include technical specifications like tw-envelope.mod, tw-leaf.mod, and tw-regional.dtd, were pre-announced in June 2020, with feedback from stakeholders leading to the final release.
Initially, the eCTD standard will apply primarily to New Drug Applications (NDAs), especially for new chemical entities, and aims to improve submission accuracy and reduce review times.
This transition to eCTD will help the TFDA align with global regulatory practices, making it easier for pharmaceutical companies to submit applications not only in Taiwan but also across multiple regions.
PharmReg Neoteric is providing regulatory solutions, supporting the TFDA in implementing eCTD validation and review tools to further enhance submission processes.
For more info do visit : https://www.cde.org.tw/eng/drugs/
