Periodic Safety Update Reports (PSURs) submission process has significantly undergone a transformation by the CDSCO, marking a pivotal shift in regulatory submissions in India. From 26th February 2024, the process for submitting Periodic Safety Update Reports (PSURs) transitions to a fully online system via the Sugam portal, an initiative aimed at enhancing efficiency, transparency, and compliance within India’s pharmaceutical regulatory framework. This directive mandates the exclusive use of the Sugam portal for the submission of PSURs, effectively discontinuing physical submissions from 11th March 2024. This is part of a broader effort to streamline medical device and drug registration processes under CDSCO guidance.

Impact on Stakeholders and Understanding the Online Periodic Safety Update Reports Submission Process 

Manufacturers, importers, and researchers in the medical device and pharmaceutical sectors are now required to adapt to the online submission protocol. This includes familiarization with the portal’s checklist, ensuring accurate and complete documentation in line with regulatory guidelines. Morulaa helps manufacturers in adhering to these regulatory guidelines, ensuring the PSUR’s format and content meet CDSCO’s standards. The overall process is as below- 

1. Preparation of PSURs – The preparation phase is critical, requiring the compilation of safety data and relevant information over a specific period. Morulaa helps manufacturers ensure compliance with CDSCO and MD-14 requirements, focusing particularly on the medical device registration process.
2. Accessing and Navigating the Sugam Portal – Morulaa assists in account creation and navigation within the Sugam portal, streamlining the login process and guiding clients through to the PSUR submission section.
3. The Submission Process – Morulaa helps manufacturers go through the checklist and prepare all necessary documents, ensuring that every submission meets CDSCO and MD-14 guidelines, adhering strictly to the medical device registration standards.
4. Post-Submission Steps – Morulaa continues to offer support post-submission, helping clients monitor their application status, respond to regulatory queries, and comply with any additional information requests.
5. Key Considerations
   • Deadline Compliance: Timely submissions are very important. Morulaa works with manufacturers to meet all regulatory deadlines, avoiding potential non-compliance issues with medical device registration.
   • Data Integrity: Morulaa emphasizes the importance of accuracy and completeness in data submission which is critical for the regulatory evaluation of a drug’s safety profile under CDSCO and MD-14 standards.
   • Guideline Adherence: With a deep understanding of CDSCO guidelines, Morulaa ensures clients’ submissions are fully compliant, facilitating a smoother review process.

Conclusion

The transition to online PSUR submissions represents a significant step forward in India’s pharmaceutical regulatory environment. The launch of the National Single Window System (NSWS) portal and efforts towards a Digital Drugs Regulatory System (DDRS) reflect a comprehensive approach to simplifying regulatory compliance, enhancing the ease of doing business, and ensuring the safety and efficacy of pharmaceutical products in India.

It aligns with global trends towards digitalization, promising enhanced efficiency, transparency, and regulatory compliance. Morulaa offers comprehensive services tailored to the online PSUR submission process. To know more, contact Morulaa on [email protected] or Click Here.