The development of health products regulatory system to promote research and innovation

Main Article Content

Yuwadee Patthanawong
Prapon Aungtrakul
Winid Ausawadkidwiree
Worasuda Yoongthong
Ananchai Asawamekin
Kornkanok Naedtip

Abstract

Several locally researched health products have failed to be approved and marketed, thus it is an urgent need to develop the effective approval system for health products under development in parallel with consumer protection. We therefore conducted the descriptive action research to develop details of the registration system model for researched medicinal products in order to extend the system to routine work and other health products innovation regulatory system. We found that the regulatory system for health products was developed slowly in comparison with development of health products in global market. Therefore, the health products regulatory system need to be developed by pooling all works of health products together, then the approval processes can be reprocessed in a holistic manner. In order to continuously develop flexibility of the system, the communication platform must be established by incorporating the consultation system with current health product approval system. This allows timely revision or issuance of necessary guidelines and regulations for researched health products under the basis of international standard and good regulatory practice, especially for product classification system and appropriate guidelines for each product class. The single window for health product approval will facilitate service efficiency and facilitate the implementation of digital government policy. In long term, the competency of both government and private networks needed to be developed continuously together with the strategy to change working attitude of the government regulatory officials from regulators to be a partner of investors and researchers. The facilitator role has to be justified with effective management of conflict of interests to ensure transparency.

Downloads

Download data is not yet available.

Article Details

Section
รายงานการวิจัย

References

1. ประพนธ์ อางตระกูล วินิต อัศวกิจวิรี วรสุดา ยูงทอง อนันต์ชัย อัศวเมฆิน วรรษมน อ่อนดี และกรกนก เนตรทิพย์. (2560, มกราคม – เมษายน). การพัฒนาระบบต้นแบบของการขึ้นทะเบียนตำรับยาระหว่างการวิจัยเพื่อเพิ่มประสิทธิภาพในการผลิตยาชีววัตถุและยาจากสมุนไพร เพื่อการพึ่งพาตนเองและส่งออกของประเทศไทย. วารสารอาหารและยา, 24(1),20-32

2. ASEAN GOOD REGULATORY PRACTICE (GRP) GUIDE Endorsed by the 2/40 SEOM Meeting 2-4 February 2009, Bangkok, Thailand.

3. World Health Organization. Marketing Authorization of Pharmaceutical Product with Special Reference to Multisource (Generic) Product: A Manual for National Medicines Regulatory Authorities (NMRAs). Spain: paprika-annecy.com; 2011.

4. Asian Harmonization Working Party Technical Committee. Playbook for Implementation of a Medical Device Regulatory Framework, AHWPTC/OB/R001:2014, 2014.