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Overview of CTGTP importer's, wholesaler's and manufacturer's licences

Understand the licensing requirements before you import, wholesale and manufacture cell, tissue or gene therapy products (CTGTP) in Singapore.

Overview

Companies dealing in the manufacture, import and wholesale of CTGTP are termed manufacturers, importers or wholesalers respectively. The regulatory control of a manufacturer, importer or wholesaler is dependent on the degree of manipulation of the CTGTP which they are dealing in.

Manufacturers, importers and wholesalers handling minimally manipulated CTGTP do not require licences but are required to notify HSA prior the start of their manufacturing, importing or wholesaling activities. They are also required to comply with the respective duties and obligations as specified in the CTGTP Regulations.

Manufacturers, importers and wholesalers handling a CTGTP which is not minimally manipulated, must obtain the required licences as follows.

Importers and wholesalers 

Requirements for importers and wholesalers

Import or wholesale of CTGTP for clinical use

An importer’s licence for CTGTP (CTGTPIL) and a wholesaler’s licence for CTGTP (CTGTPWL) are required for the import and wholesale of CTGTP, respectively. Your company must comply with the Good Distribution Practice (GDP) standard before these licences are granted to you.

If you are the product registrant and have outsourced the import and wholesale activities (including the invoicing to another company), you do not need to hold these licences yourself. However, the above licensing requirements and GDP compliance apply to the company that you have outsourced the activities to.

If your company is involved in both import and wholesale of CTGTP, you may bundle the applications for both the importer's licence (CTGTPIL) and wholesaler's licence (CTGTPWL). The fee of a bundled application is lower than the application fees of separate licences. However, you cannot apply the bundling of licences if your company’s importer’s licence is for restricted activity only.

Import and wholesale of unregistered CTGTP for patient's use

Companies who import unregistered CTGTP for named patient(s) will require an approval via the Special Access Route (SAR) from our Advanced Therapy Products Branch prior to each import. In addition, a CTGTPWL is also required if the company is importing the unregistered CTGTP on behalf of the healthcare institution where the patient is being treated.

Import of CTGTP solely for export, scientific education, research and development or non-clinical use

If your company is only involved with these activities, you can apply for a CTGTPIL (Limited Scope) at a lower fee. You may further decide if you should apply for an annual (valid for multiple consignments over one year) or a single consignment (one-time only) CTGTPIL (Limited Scope), according to your company's operational needs.

A CTGTPWL is not required for the wholesale of CTGTP imported under the CTGTPIL (Limited Scope).

Import or wholesale of unregistered CTGTP for use as clinical research materials only

You do not need to apply for an importer's licence (CTGTPIL) or a wholesaler's licence (CTGTPWL) in this case.

However, you will need to submit a Clinical Research Material (CRM) notification to our Innovation Office & Clinical Trials Branch prior to the import and supply of an unregistered CTGTP for use as CRM.

Import and wholesale of CTGTP by licensed CTGTP manufacturers

If you hold a valid manufacturer's licence for CTGTP (CTGTPML), you do not need a:

  • CTGTP importer’s licence (CTGTPIL) to import a CTGTP required for carrying out the manufacture of your CTGTP in accordance with your CTGTP ML. This includes CTGTP required for further manufacturing in Singapore, such as secondary packaging activities.
  • CTGTP wholesaler’s licence to wholesale the CTGTP that you have manufactured in accordance with your CTGTPML.

Responsible Person

The CTGTPIL or CTGTPWL holders must appoint one or more persons as a Responsible Person to be named in each licence. The Responsible Person must discharge the duties imposed by the terms of the licence and should be contactable by the Authority at any time. This person is employed and appointed by the licensee to implement and maintain an effective quality management system that meets the Good Distribution Practice (GDP) standard where required. There is no professional certificate requirement for the responsible person.

The Responsible Person must have:

  • Adequate knowledge of the activities to be carried out and of the procedures to be performed under the licence
  • Relevant working experience relating to those activities and procedures
  • Practical experience in the handling, storage and distribution of CTGTP to ensure their quality

 

Manufacturers

Requirements for manufacturers

Manufacture of CTGTP for clinical use

All local manufacturing facilities (including contract manufacturers, healthcare institutions and commercial manufacturers) engaged in the manufacture (including secondary packaging) of CTGTP must have a valid manufacturer's licence for CTGTP (CTGTPML). Your company must comply with the HSA Guidelines on Good Manufacturing Practice (GMP) for CTGTP  before the CTGTPML is granted.

You are advised to level up your company's quality management system to meet the GMP requirements for the CTGTPML during the grace period.

If you hold a valid CTGTPML, you do not need:

  • a Form A Poisons Licence (FAPL) to import and store products containing poisons required for carrying out the manufacture of your CTGTP in accordance with your CTGTPML. Such products include active pharmaceutical ingredients or substances required for quality control testing such as test reagents.
  • a CTGTP importer’s licence (CTGTPIL) to import a CTGTP required for carrying out the manufacture of your CTGTP in accordance with your CTGTPML. For example, CTGTP which requires further manufacturing such as secondary packaging in Singapore.
  • a CTGTP wholesaler’s licence to wholesale the CTGTP that you have manufactured in accordance with your CTGTPML.
  • an importer’s licence under the Health Products Act for the import of a health product that is required for carrying out the manufacture of your CTGTP in accordance with your CTGTPML.

Manufacture of unregistered CTGTP for use as clinical research materials only

You do not need to apply for a CTGTP manufacturer’s licence (CTGTPML) in this case.

However, you will need to submit a Clinical Research Material (CRM) notification to the Innovation Office & Clinical Trials Branch prior to the manufacture of an unregistered CTGTP for use as CRM.

Manufacture of unregistered Class 2 CTGTP by healthcare institutions

Healthcare institutions (HCI) manufacturing unregistered Class 2 CTGTP for supply to patients are not required to register the product. However, the HCIs must comply with the following:

  • Patient should be informed that the product is not registered with HSA and has not been evaluated for its quality, safety and efficacy. Prior consent should be obtained from the patient before its use
  • Requirements stipulated by MOH on the use of in-house manufactured CTGTP; and
  • Respective duties and obligations for manufacturers and suppliers as specified in the CTGTP regulations, including duties to maintain records of manufacture, maintain records of receipt and supply, maintain system of traceability, maintain records of defects and adverse effects, report defects and adverse effects and to notify the Authority concerning recall.

 

In addition, HCIs or contract manufacturers engaged by the HCIs must obtain a CTGTPML for the manufacture of a CTGTP which is not minimally manipulated. Existing manufacturers who have already been manufacturing CTGTP for clinical use before the implementation of the CTGTP Regulations are given a 2-year grace period til 28 Feb 2023 to comply with GMP requirements and the CTGTPML is not required during this period.

Responsible Person

The CTGTPML holder must appoint Responsible Persons (RPs) to be named in the licence for production and quality operations.

The RPs must discharge the duties imposed by the terms of the licence and should be contactable by the Authority at any time.  The RP must be employed and appointed by the licensee to implement and maintain an effective quality management system (QMS) that meets HSA Guidelines on Good Manufacturing Practice (GMP) for CTGTP. There is no professional certificate requirement for the RPs.

The RPs must have:

  • Adequate knowledge and of the activities to be carried out and of the procedures to be performed under the licence.
  • Relevant working experience relating to those activities and procedures.
  • Practical experience in production supervision or in testing and checking to ensure the quality of CTGTP.
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