Thai FDA Reduces Application Review Time

Taking Action to Realize the Prime Minister’s Policy

On February 21st, 2024, the Thai FDA gave a press release responding to the Prime Minister’s policy to increase service potential by providing data to demonstrate that their digital work system has optimized market access by reducing application processing time. Additionally, the Secretary General emphasized the TFDA’s continued commitment to consumer safety and gave assurances that a synthesis of health product security and entrepreneurial development are a top priority. This is welcome news as the TFDA recently implemented new regulations in 2021 and are keeping a close eye on their performance and implementation.

The press release for this development can be found here. For an English translation, please click here.

TFDA Halves Application Review Times

After reviewing 245 health product approval processes, the TFDA has reduced the steps and service times for operators. For cases of permission requests to produce or import medical devices, the TFDA has reduced the total number of service days by 50 percent or more. Based on data gathered by the TFDA, there has also been a much more expedited review of product registrations without Expert Review, with a reduction of 215 to 86 working days.

It was Dr. Narong Aphikulwanich, the Secretary of the Food and Drug Administration in Thailand, who announced that the policy was being changed after an order by Chonnan Srikaew, the Minister of Public Health, who was acting on the Prime Minister’s new policy declaration.

The FDA One Platform and Other Updates

The TFDA holds its service system in high regard, which is why it has been continuously updated. The FDA One Platform consists of e-Service, e-Submission, e-Payment, e-Review, e-Tracking, and e-License. What’s more, an e-Consult system which boasts online consulting services. Use of the FDA One Platform enables service recipients to access service any time and any place from all around the world thus reducing cost and travel time. The One Platform aligns with the FDA’s concept of “Smart FDA: Anywhere, Anytime, Anyone”. Before the One Platform, service users had to allot time for each application procedure as their physical presence was required. With the One Platform, in-person application review is no longer required. On top of that, the TFDA has also reduced its internal review times. Overall, service users should be pleased with this comprehensive time reduction and accessible service system. 

One Stop Service Center (OSSC)

The OSSC building is a new heath product service center meant to house Smart FDA operations (i.e. the One Platform, and Care D+ Heart). It is the epicenter of innovation, technology and digital working systems for the Thai FDA. By centralizing these operations, the FDA aspires to continue providing service users with convenient, concise, and timely service(s).

FDA Care D+

In addition to these procedural changes, the TFDA has established the FDA Care D+  Coordination Team to personify the new online platform. For service users in need of human guidance, the Care D+ Coordination Team is there to help. Pointedly, they have employed the slogan: “your heart, our heart”, to demonstrate empathy, promote understanding and reduce any communication gaps. 

To read more about the One Platform, OSSC, and Care D+ Heart, please see the Executive Activity Announcement from the TFDA posted December 8th, 2023.

With regard to questions or comments,  feel free to contact Asia Actual today.