SPECIAL TALK
BY FDA
26
JUN 2017
FOOD FOCUSTHAILAND
After facing delays in the approval process of health products, the
Food and Drug Administration (FDA) has submitted a proposal to the
Prime Ministry and Head of the National Council for Peace and Order
(NCPO) toexercisepower underArticle44of the InterimConstitution to
speedup process.
TheNCPOapproved theproposaland issuedaHeadofNCPOOrder
No.77/2016Re: IncreaseEfficiency inHealthProductsApprovalProcess.
The bill will allow consumers to access and choose a wider range of
quality health products at affordable prices. This will boost the national
economy and enhance competitiveness of health products businesses
in ASEAN and global markets. Nonetheless, the bill also encourages
activities inhealth innovations fromnational researchanddevelopment,
and increase theeffectivenessof theapproval processboth in thecentral
and local agencies offices.
Dr.Wanchai Sattayawuthipong, SecretaryGeneral of FoodandDrug
Administration, revealed thedelay inapprovalprocesswasoccurred from
insufficient experts to review and evaluate the application documents.
Theproblempostsas themainobstacle for thecountry’seconomicpolicy
suchasThailand4.0andStart Up. So far, theFDAhas beenworking to
solve the issue, but inorder toachieve sustainable solution it hadasked
the head of NCPO to apply the order under Article 44 of the Interim
ConstitutionB.E.2557 (2014) to end theproblem.
OnDecember 27, 2016, the head of NCPO, with the approval from
thecouncil, issuedanorderNo.77/2016Re: IncreaseEfficiency inHealth
ProductsApprovalProcess.TheorderwouldgreatlybenefitThai citizens
in many aspects regarding health products, including medicines, food
products,medicaldevices,cosmetics,psychotropicsubstances,narcotics
orhazardoussubstances.Thepubliccanaccesswidervarietiesofhealth
products, whichwiden their choice to health promotion. For example, in
caseof drugs, ifmore thanonemedicines for oneparticular diseaseare
authorized, the public will have choices to purchase cheaper drug in a
trade competitive environment. Moreover, the order will accommodate
the approval process to bemore convenient, fast, and effective for both
thecentral and regional agencies, as theycanoutsourceeitherdomestic
and foreignexperts,expertorganizations,governmentagenciesand
privatesectors,apart fromFDAandMinistryofPublicHealth to review
reference papers, analyze health products, or inspect premises or
according to FDAannouncement. However, these experts shall be
enlisted by theFDAprior toprocessing.
Not only that allThaiswill gain theutmost benefit from theNCPO
Order under Article 44, this will encourage a revolution in health
productsapproval, andconsumer protectionsystems inmodernand
effective way. This will also drive national economy and increase
competitiveness inhealthproductsboth inASEANandglobalmarket,
as well as the promotion of innovative health products through
sustainable research and development in Thailand. The FDA will
complete approval process expeditiously in accordance with the
timelineprovided inPublicmanuals, aswell as notify entrepreneurs
in compliance with the Licensing FacilitationAct, B.E.2558 (2015).
The FDA ensures entrepreneurs to provide fast, accurate and
transparent service tobea driving force for national economy.
The setting of fees for experts, organizations, or expert
organizations registration, and the entrepreneurs will also be
considered by representatives from Office of the Public Sector
DevelopmentCommission (OPDC),consumerprotectionassociation/
foundation, health product entrepreneurs, andMinistry of Finance.
The income isaimed tobepaid tospecialistswho takepart inpaper
revision, health products analysis, premises inspection, or health
products approval processes, as well as use for other beneficial
projects for consumers protection and improve effective working
system. The spending shall be in compliance with terms and
regulationsannouncedby theMinistryofFinance,whileprocurements
will be followed the Regulations of theOffice of the PrimeMinister
on Procurement. All expenses will be monitored by the Ministry of
FinanceandTheOfficeof theAuditorGeneral of Thailand (OAG) to
ensure honesty, transparency and utmost benefit toThailand.
FDAtoStreamline
HealthProductsApprovalProcess
ViaArticle44
withAimstoConsumerProtectionandServiceEfficiency
