For locally registered products in Singapore, the management of investigational product (IP) for clinical trials is the most critical step, which should comply with the ICH E6 Good Clinical Practice (GCP) Guideline. For this, the HSA, Singapore, has updated the guidance for “Alternative Approaches for Investigational Product Management for Clinical Trials of Locally Registered Products” in January 2026, aligned with the ICH E6 (GCP) guideline.
The new update aims to maintain product integrity, product use in accordance with the trial protocol, and ensure the participant’s safety.
HSA IP Management Update
The newly issued investigational product management HSA guidance is applicable for:
- A Clinical Trial Certificate (CTC), Clinical Trial Authorisation (CTA), or Acceptance of Clinical Trial Notification (CTN) issued by HSA; and
- Where the Investigational Product is a locally registered therapeutic product or locally registered Class 2 Cell, Tissue, and Gene Therapy Products (CTGTP).
- IP receipt, storage, dispensing, accountability, return, and destruction.
However, the alternative approaches will not apply to the need to maintain written instructions for IP Management, IP Repackaging, and IP Labelling.
What’s New in HSA’s 2026 IP Guidance
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Delegation of the responsibilities
As the investigator/institution is responsible for IP management, including accountability, handling, dispensing, administration, and return. However, the new update mentions that these activities may be delegated to persons or parties involved in IP management, and a record (e.g., delegation log) should be maintained.
The proportionate approach given in the new update for delegation documentation gives the flexibility that it may not be required for the IP management activities performed as part of routine clinical practice. However, an alternative documentation is recommended to clarify their involvement, e.g., an email to the relevant Head of Department or a note to File, etc.
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Investigator Oversight
According to the new update, the investigator is responsible for maintaining appropriate oversight of the persons or parties involved in IP management to ensure the rights, safety, and well-being of the trial participants and the reliability of data.
The proportionate approach should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.
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- The level of investigator oversight should consider the Following factors should be considered for the level of investigator oversight:
- characteristics of the investigational product
- route and complexity of administration
- level of existing knowledge about the investigational product’s safety
- marketing status.
However, for a registered IP managed in accordance with clinical practice, less intensive investigator may be sufficient.
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Qualification and Training
HSA IP Management guidance outlines that persons should be appropriately qualified and adequately informed about the protocol, investigational product, and assigned trial activities. Training should include the delegated trial activities beyond the usual training and experience.
For a registered IP managed as per the routine clinical practice, the entire protocol training is not necessary. However, trial-related information about IP management (e.g., Pharmacy Manual, written instructions, etc.) and relevant updates should be provided to them, and training documentation should be maintained.
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IP Receipt
The investigator is responsible for IP receipt and inventory records.
As an alternative approach, an inventory log is not required for IP received from pharmacy stock. If the pharmacy does not have a batch number and expiry date tracking system, information should be maintained in an IP dispensing log or equivalent documentation.
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IP Storage
The investigator should ensure the storage of the IP in compliance with the sponsor specifications and applicable regulatory requirements.
As per the revised update, the investigator should ensure:
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- Availability and maintenance of written instructions for IP storage
- Secure area with limited access and within the recommended temperature range for storage
- Maintenance of temperature records
- Availability of an alarm system to detect temperature excursions.
- Reporting to the sponsor for any temperature excursion, quarantine the affected batches, and the availability of a back-up plan
- Calibration and maintenance of the storage equipment and reports
Alternative approaches for IP storage:
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- If the storage temperature is centrally monitored, separate IP storage records may not be required.
- For locally registered products stored at the pharmacy, if the institution does not maintain temperature records but has an alarm system in place, then the sponsor is responsible for assessing the maintenance of the product within the required temperature range.
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IP Preparation, Dispensing, and Accountability
Investigators should maintain IP use records by each trial participant, including the doses provided as per the protocol, and should ensure IP use in compliance with the approved protocol.
Hence, it is advised to maintain the IP preparation records, IP dispensing and accountability logs, and IP administration records, as applicable.
As an alternative measure, if the compliance is not required for the protocol, IP dispensing, and accountability logs may not be required. However, the batch number and expiry date should be documented on the prescription or an alternative document.
Separate IP preparation records may not be necessary if the IP is a registered product maintained with routine clinical practice.
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IP Return and Destruction
IP return and/or destruction records should be maintained by the investigator.
If the institution’s pharmacy system for pharmaceutical waste destruction is used, destruction records may not be required. However, IP returns and the institution’s SOPs for the destruction of pharmaceutical waste should be documented.
Regulatory Impact of HSA’s 2026 IP Management Update
- Reduced burden on investigator sites
The newly issued update reduces the documentation requirements in cases where the IP is maintained in accordance with the clinical practices.
- Flexibility in the IP management processes
The update provides proportionate and risk-based alternative approaches to IP management for locally registered products.
- Compliance with regulatory requirements
Proportionate and risk-based approaches given in the new update for IP management are in compliance with ICH E6 (GCP) requirements.
Conclusion
January 2026 guidance on Alternative Approaches for Investigational Product Management by HSA is a significant update for the clinical trials regulatory framework. The alternative approaches given in the update provide flexibility to the sponsors and investigators while still maintaining compliance with the ICH GCP standard.
With the evolving regulatory requirements, it is necessary to be updated, interpret the requirements accurately, and maintain compliance with regulatory standards.
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