16 January, 2017
The year 2016 saw a number of healthcare-related initiatives implemented by the Government with the aim of developing and improving the competitiveness of Thailand's healthcare sector. These initiatives include, amongst others, the introduction of an electronic product registration system for broader categories of healthcare products – including more complex healthcare products, obtainment of the Pharmaceutical Inspection Co-operation Scheme membership by the Food and Drug Administration (FDA) and its attempt to reclassify drug classifications to be more in line with international standards.
Before the dawn of 2017, the Government had moved to continue such developments with the issuance of the Order of the National Council for Peace and Order (NCPO), Order No. 77/2559, pursuant to the authority granted to the NCPO under the Interim Constitution of the Kingdom of Thailand (Order). The Order was promulgated in the Government Gazette on 28 December 2016.
The purpose of the Order is to increase the efficiency of the approval processes related to healthcare products (i.e. drugs, foods, medical devices and cosmetics).
The "approval processes" under the Order are defined to include the evaluation of applications, the review of documents, the evaluation of academic references, the inspection of business premises, as well as any other approvals required for healthcare products.
To this end, the Government has recognized the need to have in place an approval mechanism which is fast, efficient and able to be concluded within the timeframes set by the law. It is hoped that the improvements to the approval mechanisms will allow the public to access and choose a better range of quality healthcare products. Ultimately, such improvements would also ensure that Thailand has a modern and efficient approval system that can be a driving force for Thailand's economy and increases its competitiveness in the global market. The Order is also in line with Thailand's continuing role in the ASEAN harmonization process for healthcare products.
The Order mainly seeks to provide a framework for the FDA to outsource certain areas of the work required in the approval process. This includes the possibility of enlisting experts outside of the FDA and the Ministry of Public Health, either from the public or private sector.
Additionally, the Order also requires the FDA to complete all approval processes for healthcare products expeditiously and in accordance with the timeframes set in the manuals provided to the public.
Whilst it remains to be seen whether the Order will have any real effect on the current timeframes of the relevant approval processes, specifically in the short term, the Order nevertheless provides yet another evidence of the current Government's commitment to improving the healthcare sector in Thailand and marks a propitious start for the healthcare industry in Thailand for 2017.
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