Herbal Product Registration Situation on the Thai Food and Drug Administration’s Auto e-Permission in 2020

Abstract

Background: Since 14 February 2020, the Thai Food and Drug Administration (FDA) has issued an Auto e-Permission for herbal product registration. Therefore, having a comprehensive understanding of the application is a further improvement to the registration process.

Objective: To examine the completeness and accuracy of the FDA's herbal product registration via the Auto e-Permission system and to study the problems of using the system of authorized entrepreneurs who got the licenses.

Methodology: This was a descriptive study. It was collected data as a retrospective study from 14 February to 31 December 2020 by using the FDA's herbal product formula registration databased. Besides, it used a questionnaire about the use of system problems of the authorised entrepreneurs by accidental sampling at 15 samples from a population as 30 entrepreneurs.

Results: The toll for herbal product registration data on the system was 91 licenses. It found that these licenses had completeness and correctness according to Thai FDA’s conditions at 2.20%. There was one item completely submitted, which was label and leaflet. The three parts as incomplete sections were the commitment of herb medicine list conditions as the list of national essential medicine appendix that was a hospital formula, the active substances analysis results, and the commitment of conditions for notification of drug recall list at 75.00, 73.08 and 42.86%, respectively. When comparing in each group of product registrations with incomplete leaflets, the top three ranking was: herbal infusions, andrographis capsules, and balms by 100.00, 80.00 and 58.82%, respectively. In terms of inaccuracies of the registration information, when comparing the registration quantity in the similar proportions of the first three, it was found that the production method, the commitment for licensees who applied for registration of traditional drug formulas for reporting serious adverse drug reactions, and the commitment of conditions for notification of drug recall list by 54.44, 40.98, and 38.46%. When studying the details of the information on the stated label, most of them that incorrect included the name and quantity of active ingredients, product name, and indications 47.13, 26.14, and 22.99%, respectively. The analysis of product leaflets found that the dose and use, the name and quantity of active substances, and product name were most incorrect 54.55, 46.59, and 25.00%. Moreover, 60% of the sample indicated that during the period, they encountered problems using the automation system, an average of 1.54 times overall. Most of them found that the system failed to save data and unable to upload attachments that was the same problem 46.67%, followed by system unavailable/closed 40.00%, unable to record data and the system failed to save uploaded documents 33.33%.

Conclusion: The automatic authorization system used in herbal product registration was able to completely and accurately filter data at 2.20%, and most users experienced issues using this automatic authorization system. However, the registrations that were not completely correct during the period of time had informed the entrepreneurs to correct the registrations in order to control the risks. Therefore, to improve the efficiency of the automatic authorization system, an officer who has an in-depth knowledge of the authorization issues should work closely with the system designers/developers to design a new permission system. While the new authorization system is being developed, the FDA should streamline the information notification procedures and the number of documents to be submitted through the system. There should also be a step of document reviewing process, manually done by the authority before authorizing a herbal product formula registration using the existing automatic authorizing system. The herbal medicine products on the market should be monitored and illegal products should be strictly dealt with to ensure the safe consumption of standard quality products.