Duties and obligations of CTGTP registrants, manufacturers, importers and suppliers

CTGTP registrants, manufacturers, importers and suppliers (including wholesalers, hospitals, clinics, nursing homes and retail pharmacies, where relevant) are required to fulfil the duties and obligations stipulated in the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021.

All relevant records must be made available to HSA upon request.

These duties and obligations include the following:

Maintain Traceability System

CTGTP registrants, manufacturers, importers and suppliers are required to establish and maintain a system to ensure traceability of the product and its starting and raw materials, including all substances that may come into contact with the cells or tissue it contains during any of the following processes, where relevant:

• Sourcing

• Procurement

• Processing

• Testing

• Packaging

• Storage

• Transport

• Delivery to the hospitals, clinics, nursing homes or retail pharmacies where the CTGTP is used, administered, supplied or disposed

A traceability system is also to be maintained at or from the hospital, clinic, nursing home or retail pharmacy that is supplied with the CTGTP to enable linkage to the patient who received the CTGTP.

Records Retention period

At least 30 years after the expiry date of the CTGTP

Maintain Records of Manufacture

Manufacturers of CTGTP for clinical use are required to maintain records of manufacture, including but are not limited to records of:

• Batch processing

• Release testing

• Manufacturing deviations

• Change control

• Qualification and maintenance of premises and equipment

• Environmental monitoring

Records of manufacture are not required to be maintained for the manufacture of CTGTP solely for scientific education, research and development, or non-clinical purpose

Records Retention Period

At least one year after the expiry date of the CTGTP; or 5 years after the date of manufacture of the CTGTP, whichever is longer.

Maintain Records of Receipt and Supply

CTGTP registrants, manufacturers, importers and suppliers are required to maintain records of each receipt and supply of the CTGTP containing all the following information:

• Name of the CTGTP (proprietary name or appropriate non-proprietary name)

• Dates on which the CTGTP is received and supplied

• Name and address of the person from/to whom the CTGTP is received/supplied, accordingly

• Quantities of the CTGTP received and supplied

• Identification number (including the control number, lot number, batch number or serial number) of the CTGTP received and supplied.

*Records of receipt not applicable for manufacturers of CTGTP

Records Retention Period

At least 30 years after the expiry date of the CTGTP

Maintain Records of Defects and Adverse Effects

CTGTP registrants, manufacturers and importers are required to maintain records of any defect or any adverse effect arising from the use of the CTGTP. The records must contain all the following information:

• Name of the CTGTP (proprietary name or appropriate non-proprietary name)

• Date on which the importer first became aware of the event or occurrence

• Identification number (including the control number, lot number, batch number or serial number) of the CTGTP

• Nature of the defect or adverse effect

Records Retention period

At least 2 years after the expiry date of the CTGTP

Report Defects and Serious Adverse Reactions

CTGTP registrants, manufacturers, importers and suppliers are required to report any defect or any serious adverse reactions arising from the use of their CTGTP to HSA.

Please refer to Adverse event reporting of cell, tissue or gene therapy products (CTGTP) for reporting guidelines and timelines.

Notify HSA Concerning Recall

CTGTP manufacturers, importers, suppliers and registrants are required to notify HSA of their intended recall of a CTGTP as soon as possible within 24 hours before initiating the recall.

Please refer to Product defect reporting and recall procedures for cell, tissue or gene therapy products (CTGTP) for the guidelines and timelines.