Laos’ Food and Drug Department (FDD) has been using a new online registration system for drugs since the beginning of the year. The system, which was implemented following the November 2025 issuance of Notice No. 5960/FDD, became the official pathway for submissions on January 1, 2026. Since that date, paper-based registrations have no longer been accepted. This marks a significant advancement in the digitalization of regulatory processes in Laos.
As the online system is now the exclusive platform for registration, renewal, and amendments, companies that have not yet aligned their processes to the new system should act promptly to ensure a smooth transition. To assist with this, the FDD will conduct periodic training sessions on the use of the online registration system, which will be delivered either in person or remotely, depending on operator demand.
To start using the system, drug and medical device manufacturers, as well as import-export companies, that have not yet registered must submit a formal request identifying the authorized personnel who will access the platform, after which they will be issued user accounts and access codes. Each request must be accompanied by the company’s enterprise registration certificate (incorporation certificate), a copy of the identity card or passport of each designated user, and a scanned copy of their signature. There is no restriction on the number of users per company, allowing flexibility to meet operational needs.
Companies that already hold accounts and access codes from the trial phase may continue using them and may apply for additional accounts if needed.
Additional Requirements
The new system also introduces a standardized format for drug registration numbers. For example, an import drug registration number such as 06 I 4040/15 will be changed to 06-IM-04040-15, and a domestic drug registration number such as 06 L 4040/15 will be changed to 06-LM-04040-15. Companies are required to update packaging to reflect the new format within two years and must report progress periodically to the FDD.
For pharmaceutical products that require sample analysis prior to registration or renewal, manufacturers or companies must send samples directly to the National Food and Drug Analysis Center and upload the sample receipt into the online system.
