Policy obstacles being addressed in drug licensing and renewal

Policy obstacles being addressed in drug licensing and renewal

The Advisory Council for Drug Registration proposes addressing policy and institutional obstacles related to licensing and renewal of pharmaceuticals and vaccines to speed up the progress to facilitate business activities and increase the supply.

The Ministry of Health (MoH) on January 21 held a meeting in Hanoi to review the licensing and renewal of pharmaceuticals and vaccines during 2025 and orientation for 2026.

The event, chaired by Deputy Minister of Health Nguyen Tri Thuc, saw the participation of representatives of departments under the MoH, council members and experts.

Photo: MoH

The advisory council for the term of 2023-2026 operates according to the principles on regulating the registration of drugs and drug raw materials for circulation, as well as traditional medicines and medicinal herbs.

According to the council, in 2025 it reviewed nearly 9,500 applications, including more than 5,900 fresh applications, 2,400 renewal applications, and about 1,190 applications for amendments or additions.

The number of applications granted marketing authorisation in 2025 included more than 3,600 drugs, of which 43 were vaccines and biological products, the highest number since 2020.

Council members acknowledged that professional expertise is important, but legal issues are equally crucial. Therefore, any policy and institutional obstacles related to licensing, renewal, or issues related to the council's operations, such as the low remuneration for experts reviewing and evaluating dossiers, need to be addressed promptly.

It was also suggested that the application of IT should be promoted to make it easier for council members to review and read clinical records.

Deputy Minister of Health Nguyen Tri Thuc. Photo: MoH

Deputy Minister Thuc highly appreciated and acknowledged the important contributions of teachers, and experts as members of the council for helping the management agency ensure the supply of medicines, vaccines, and biological products to serve the needs of epidemic prevention and control as well as exam and treatment.

He expressed his hope that in 2026, based on the increasing practical needs in people's healthcare, the members of the council will continue to leverage their experience and dedication in performing the council's functions and tasks to improve the quality of dossier evaluation.

"The intelligence and dedication of teachers and experts are valuable and worthy of respect. They act as a rigorous filter for the Drug Administration of Vietnam (DAV) and the Traditional Medicine Management Department before granting or renewing registration certificates for drugs, vaccines, and medical biological products," he said.

The deputy minister requested the leaders of the DAV and the department to take note of the issues, promptly develop a plan to resolve them, and report to the ministry's leadership.

VIR