Biomanufacturing (Large-scale Production) Facility
Find out more about requirements for a biomanufacturing facility.
Last updated 23 December 2025
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General
Biomanufacturing (Large Scale Production) Facility refers to a facility involved in the use of large quantities of cells or other living microorganisms to produce commercially viable products such as vaccines, monoclonal antibodies, and proteins for medicinal use; and is required to comply with Good Manufacturing Practices.
Requirements for registration as a biomanufacturing facility
The facility must have a Biosafety Committee composed of the members stipulated in the Sixth Schedule of the Biological Agents and Toxins Act (BATA).
The facility must put in place all safety and security requirements (refer to the Biorisk Management Standard for Large-scale Work With Biological Agents for details) which are commensurate with the risks posed by the scheduled biological agent and toxin, and the activities undertaken. These shall be supported by a compliance verification (inspection or audit) report.
All members of the facility shall comply with the duties and responsibilities stipulated in Part 5 of the BATA.
Additional requirements for facilities planning to handle First Schedule Part 2 biological agent and/or Fifth Schedule toxin include:
the facility must be gazetted as a protected place under the Infrastructure Protection Act and meet the requirements stipulated in the Physical Security Workgroup checklist.
personnel working in the facility must be security vetted by the relevant authority.
Information and/or documents needed for registration as a biomanufacturing facility
Please refer to FAQ – Biomanufacturing Facility.
First Schedule Part I biological agents
Proof that the facility is a certified facility
Proof that the facility has been granted a prior approval to possess the agent
Proof that approval for large scale produce of the agent has been granted
Other supporting documents that the MOH deemed necessary in the application.
First Schedule Part II biological agents
Proof that the facility is a certified facility
Proof that the facility is gazetted as a protected place under the Protected Areas and protected places Act
Proof that the facility has been granted a priort approval to possess the agent
Proof that approval for large scale produce of the agent has been granted
Other supporting documents that the MOH deemed necessary in the application.
Third Schedule biological agents
Proof that approval for large scale produce of the agent has been granted
Other supporting documents that the MOH deemed necessary in the application.
Register as a biomanufacturing facility
Submit your application via the HALP-Biosafety portal.
Fees
Currently, the Ministry of Health (MOH) does not charge any fees for the registration of a biomanufacturing facility.
However, compliance verification services (e.g. facility inspection or audit) provided by third party certifiers, inspectors or auditors (e.g. Ministry of Health-Approved Facility Certifying Body, MOH-AFCB) will be chargeable.
Processing Time
The processing time will depend on the accuracy and completeness of the information and supporting documents submitted for the application.
The application may take up to 30 working days to process, if and only if all the criteria and/or requirements for the application have been satisfied.
Validity of Registration for biomanufacturing facility
The validity of the registration of an Biomanufacturing Facility with the MOH is between 1 to 3 years, depending on risk assessment. The MOH may at its discretion, revoke or suspend the registration at any time.
FAQ
Find answers to commonly asked questions on the FAQ page.