The third annual meeting of the South-East Asia Regulatory Network (SEARN), being held at New Delhi from 23-25 April 2019 aims at stepping up collaboration among national regulatory agencies for medical products in the South-East Asia Region.
The annual consultation will build on the work done since the last meeting held in Colombo, Sri Lanka in March 2018 and deliberate on the progress made by the five working groups: Quality assurance and standards of medical products, including labs; Good Regulatory Practices (GRP), including Good Manufacturing Practices, GDP etc; vigilance for medical products; Information Sharing Platform; and medical devices and diagnostics.
Drug Regulatory Authority, the national regulatory authority of Bhutan has been playing an active role in ensuring that medicines, vaccines, diagnostics and medical devices in the country are evaluated properly and meet international standards of quality and safety.
It has also been contributing to the collaborative process at the regional level.
The third annual meeting will bring together representatives from all regulatory agencies in the South-East Asia Region and international and national experts. Kinga Jamphel, Drug Controller and Jigme Tenzin, Senior Regulatory Officer will represent the country at the consultation.
Among others, also attending the consultation will be representatives from WHO, Bill & Melinda Gates Foundation, Translational Health Science and Technology Institute, National Institute of Biologicals, Foundation for Innovative New Diagnostics (FIND), Biotechnology Research and Assessment Council (BIRAC), Indo-Pacific Regulatory Strengthening Program (RSP), Andhra Pradesh Medtech Zone (AMTZ), AMTZ Campus,Visakhapatnam, Centre of Regulatory Excellence (CoRE)
Duke-NUS Medical School, Medicines Patent Pool, United States Pharmacopeia.
WHO South-East Asia Region Member States launched SEARN at the first meeting of the Network in New Delhi, India in April 2017 to enhance information sharing, collaboration and convergence of regulatory practices across the Region to guarantee access to high-quality medical products (medicines, vaccines, devices, diagnostics).
A notable progress is the SEARN Information Sharing Platform (ISP) Gateway, which was launched at the inaugural session of the ‘2nd World Conference on Access to Medical Products-Achieving the SDGs 2030’ at New Delhi on 9 October 2018.
The SEARN ISP is progressively making publicly available information of all the 11 State Drug Regulators in SEARO accessible through a single ISP Gateway – https://www.searn-isp.org/SEARN/en/Home/index.html.
The reports of first and second meeting of the South-East Asia Regulatory Network (SEARN) can be accessed at http://apps.who.int/medicinedocs/documents/s23431en/s23431en.pdf and https://apps.who.int/iris/bitstream/handle/10665/274348/sea-hsd-394-eng.pdf?sequence=14&isAllowed=y
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