On April 28, 2025, Taiwan's Ministry of Health and Welfare issued Announcement No. Wei Shou Shi Zi Di 1141413831A, updating the Guidelines for electronic Common Technical Document for Drug Inspection and Registration (Version eCTD-R2) and the Guidelines for validation of electronic Common Technical Document for Drug Inspection and Registration (Version eCTD-V-R2). The new guidelines will come into effect on July 1, 2025. This update aims to enhance the standardization and efficiency of drug registration applications and further align with international drug filing norms.
The scope of implementation now includes post-market changes and drug license renewals.
In terms of file formats, the maximum path length limit has been adjusted to 180 characters to ensure the rationality and compatibility of the file directory structure.
Related forms and English instructions in Module 1 have been revised to be clearer and more straightforward, facilitating understanding and completion by applicants. This is particularly important for companies involved in cross-border drug filings, helping to reduce application errors caused by language and format misunderstandings.
In the application process, instructions for high and low dosage application procedures have been added, providing more specific operational guidance for pharmaceutical companies. Meanwhile, mandatory upload markers for certain nodes have been removed, and mandatory upload nodes have been adjusted to Section 1.1.1. This optimization streamlines the application process, making the submission of application materials more centralized and organized.
To align with international standards, Modules 2 to 5 of the new guidelines follow the ICH eCTD V3.2.2 specification, a widely recognized international technical requirements for registration of pharmaceuticals for human use. Taiwan's adoption of this specification enhances the international versatility and comparability of pharmaceutical registration dossiers. For pharmaceutical companies with international businesses, this enables more convenient drug registration across different regions and reduces obstacles caused by regional regulatory differences.
Additionally, Taiwan has clarified the administrative data requirements for Module 1, such as the structure of tw-envelope.xml and the checksum values of related documents. This ensures that the submitted dossiers meet local regulatory requirements while maintaining international compatibility.
This update holds significant importance for Taiwan's drug regulatory system. From the perspective of health authorities, unified standards help improve review efficiency and make the regulatory process more standardized. During reviews, regulators can more quickly and accurately access key information, reducing review time and accelerating drug approval. From the applicant perspective, while short-term adaptation to the new guidelines is required, this will help enhance the efficiency of drug research, development, and regulatory in the long term and reduce registration costs. For patients, faster drug approval means earlier access to safe and effective medications, meeting clinical needs.
To ensure the smooth implementation of the new guidelines, Taiwan's Ministry of Health and Welfare plans to hold a series of training and publicity activities to help pharmaceutical companies and relevant institutions get familiar with the new regulations. Dedicated consultation channels may also be established to address questions arising during the regulatory process. As July 1 approaches, Taiwan's pharmaceutical industry is closely monitoring the implementation progress of the new guidelines, anticipating more efficient and smooth drug registration under the new specifications, which will inject new vitality into the region's pharmaceutical industry development.
If you have registration needs in Taiwan, please feel free to contact us.
Brilliantmed's One-stop Solution assist you in obtaining marketing approvals for pharmaceutical and health products in China, China Taiwan, the United States, Europe, and major countries in the Asia-Pacific region.
