Draft Amendment of Notification on Prescription of Pharmacopoeias
To ensure that the quality, efficacy, and safety of drugs in the market are up-to-date, the Food and Drug Administration (FDA) deems that it is appropriate to amend the Notification of Ministry of Public Health re: Prescription of Pharmacopoeias, B.E. 2556 (2013) in order to update the FDA's prescribed pharmacopoeias to the most current versions, and to possibly add the Japanese Pharmacopoeia (JP) to the list.
The FDA held a public hearing on 15 August 2017 to obtain feedback from all stakeholders who would be affected by these updates. The major concern was from the manufacturers who are concerned about the production cost and timing which would certainly accelerate if they had to update the API or drug specifications to follow the new versions of pharmacopoeias. Additionally, the tentative effective date of the new notification, expected to be around the end of 2017, would provide the stakeholders with a very short transition period to adjust to the new requirements. Last but not least, several JP monographs are different from the international pharmacopoeias, therefore, the acceptable criteria for JP as a prescribed pharmacopoeia must be re-considered.
We will have more updates after the Drug Committee meeting at the end of August 2017.