As regulatory landscapes evolve, countries worldwide are embracing the adoption of electronic Common Technical Document (eCTD) submissions to streamline their Regulatory submissions processes. One such country that will soon be venturing into the realm of eCTD submissions is Singapore. This transition would mark a significant milestone in their regulatory framework, enabling efficient and standardized submission processes, fostering collaboration, and embracing digital transformation in regulatory affairs.
In this blog post, we will delve into the significance of this upcoming implementation of the electronic Common Technical Document (eCTD) format citing challenges, advantages, and opportunities for the pharmaceutical industry in this thriving nation.
- Transition and Training: Adapting to eCTD demands stakeholder training and collaboration.
- Technological Infrastructure: Robust infrastructure needed for secure storage and efficient management of electronic data.
- Regulatory Compliance: Meeting updated eCTD requirements through collaboration and technology solutions
- Submitting eCTD through the portal is an entirely paperless submission with the advantage of system validation to ensure successful receipt of the package by the HSA;
- Unlike how documents are attached in PRISM, eCTD would allow companies to submit common dossiers for multiple strengths in a single application and by uploading a single ZIP file; and
- eCTD enables content reuse without the need to re-submit documents.
- Streamlined Submissions: Faster review and approval timelines through a streamlined electronic format.
- Enhanced Data Accuracy: Improved accuracy and completeness of data with standardized templates and formats.
- Global Compatibility: Aligning with international standards for improved collaboration and information exchange.
Singapore's forthcoming implementation of eCTD signifies a progressive leap towards modernizing the regulatory landscape. Initially, the HSA will accept new drug applications, generic drug applications as well as their respective Drug Master Files (DMFs), with a phased approach and a voluntary use of eCTD for dossier submissions. The target implementation of eCTD in Singapore is Q4 2024.
The advantages and opportunities gained are enticing for the pharmaceutical industry. However, the journey does come with its set of challenges that has to be taken care of. To ensure seamless navigation of the dynamic regulatory landscape, companies can forge partnerships with trusted experts like Freyr. Embrace the future of regulatory submissions in Singapore with our unparalleled eCTD software, Freyr SUBMIT PRO, which is 21 CFR Part 11 standards compliant and has a flexible deployment model. Contact us today to learn more and embark on a journey towards enhanced efficiency and success. Request a demo today.