National Biotechnology Authority (Biotechnology Facility Registration) Regulations, 2026

Biotechnology facilities must register with the National Biotechnology Authority and obtain a separate permit before using the registered facility. Registration costs US$800 and a utilisation permit costs US$200. Both last one year; renewal costs half the corresponding original fee.

Applicants must establish an institutional biosafety committee and prepare a biosafety manual, containment measures and contingency plans within 30 days of applying. The process includes an Authority review and facility audit, with identified problems to be corrected within 30 days of receiving the audit report. Certificates and permits are tied to the approved facility and cannot be transferred.

Apply to renew registration at least 90 days before expiry and the utilisation permit at least 30 days before expiry. Facilities must allow safety inspections, report accidents immediately and submit annual returns covering projects, incidents, waste disposal, equipment records and training.

The Authority can suspend or cancel approvals for breaches, with notice and an opportunity to respond except where urgent public-interest action is necessary. Specified registration, permit and safety breaches can attract a level-12 fine, up to five years in prison, or both. The instrument does not state a separate commencement date.