The Food and Drug Administration (FDA) has published Ministerial Notifications introducing additional government fees of activities relevant to the registration, notification and amendment of applications for drugs, medical devices, foods, cosmetics, hazardous substance, narcotic and psychotropic substances, with immediate effect.
Three notifications prescribe government fees for drugs. These include: the actual fees that the FDA collects from the applicants; the maximum fees targeted for year 20th that the FDA will collect from the applicants; and the maximum fees that the FDA collects from the external experts or expert organizations who perform the document verification, product analysis, on-site inspection or drug verification.
In the past, the government fee was usually paid at the end of the registration process when applicants obtained the drug registration licenses. Now there are three types of the government fees to be paid at three different stages: when filing of an application; for document verification and on-site inspection (if required); and when obtaining the approval. The last type of fees remains the same. In addition to these fees, all consultations, both verbally and in writing, will also be charged either on an hourly or by fixed-fee basis.
However, there are some exceptions. Government fees do not apply to new drugs that are researched and developed in Thailand for public security as stipulated by the Minister, orphan drugs or registered drugs that are ordered by the FDA to be amended due to its quality and safety. There are also partial government fees imposed on domestic drug manufacturers or some types of drug registrations with specific conditions.
Given the foregoing, the FDA has further obligations to revise the citizen manuals for all healthcare products, specifically improving the process timelines and updating the registration requirements and processes to ensure faster and more efficient time management.
There will be further notifications prescribing relating payment methods. We will keep you posted on further developments in this regard.