Government Order to Increase Efficiency of the Approval Process for Healthcare Products

Following Section 44 of the Interim Constitution of 2014, the National Council for Peace and Order issued Order No. 77/2559 ("Order") to the Food and Drug Administration ("FDA") with the aim to increase the efficiency of the approval processes for healthcare products. According to the Order, the approval timeline must not exceed the time specified in the citizen manuals. The Order also aims to push forward reforms of the healthcare product approval system and the consumer protection system to make them more efficient and up-to-date . The Order was promulgated in the Government Gazette on 28 December 2016.

Pursuant to the Order, the FDA has set up sub-committees to consider methods, conditions, and official fees entailed in the approval processes of all product classifications. They will also outsource some work, such as evaluation of technical documents, analytical tests and auditing place of establishment or auditors to external experts, expert organizations, government agencies, or private and overseas organizations, to increase the convenience, speediness and efficiency of the approval processes both at the FDA and at the Provincial Public Health Offices.

Immediate activities and timelines for the FDA to accomplish for drug products include;

− To announce the highest rate of the official fees and the actual official fees, which is expected to be proposed to the Cabinet in March 2017 and implemented around April 2017;

− To announce the rules and methods to engage experts and the registration of experts, expected to be in March 2017;

− To create rules for receiving and spending money - initially anticipated to be published in the Government Gazette in February 2017; and

− To prepare the readiness of officials both at the FDA and at the Provincial Public Health Offices.

Currently, business operators pay the official fee of 10,000 Baht when applying for a modern drug import license and another 10,000 Baht per year for maintaining it. To obtain a drug registration license, the official fee is 2,000 Baht per license. The fee is a one-off charge and the license is dateless. There is no official fee to audit a pharmaceutical manufacturing facility for the renewal of a manufacturing license. However, we can expect that this year the official fees will be increased significantly.

Calculation of the highest rate of the official fee is based on main expenses and supporting expenses. Main expenses are those relating to document evaluation, document storage and logistics, and salary of the non-government personnel, pharmacists and clerks. Supporting expenses are, for example, those relating to training and development of FDA personnel.

We anticipate further details from the FDA on the actual official fees to be collected, the reform of the approval system as a whole, and what new or revised methods the FDA will implement that will facilitate the approval processes and pending applications. Most importantly, it remains to be seen what short-term and long-term strategies the FDA will adopt to speed up the approval timelines.

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