The Food and Drug Administration under the Department of Health will begin implementation of its 5-year development plan designed to accelerate the agency’s growth and further strengthen its regulatory services.
FDA Director General Nela Charade Puno said the plan has been submitted and approved. She added they are the only agency under the DOH’s Office of Health Regulation that was able to craft such a plan and get approval.
“We have to ensure that we reflect balance between protection of consumer safety and supporting ease of doing business with partners in the industries that FDA regulates,” Director Puno emphasized, during the FDA 54th Anniversary.
President Rodrigo Duterte has given the agency three marching orders: zero backlogs, 72 hours turnaround time and strengthened enforcement.
"We are committed to reduce our backlogs in applications for license to operate (LTO), Certificate of Product Registration (CPR) and legal decisions by 90 percent by the end of this year," she said. As of July 2017, the FDA backlogs have already been reduced by 33 percent.
The 5-year plan, divided into two phases, largely involves a plan to improve information technology within the agency, including the creation of a mobile app, and establishment of a management information system (MIS).
Phase 1, for implementation between 2017 and 2019, will focus on the restructuring the agency’s foundation, and will this include the MIS operational system.
The FDA shall undertake organizational reform and development, strengthen inspection and enforcement action, and upgrade facilities and tools. Further, it is aiming to Improve its policies by creating and implementing smart regulations and then strengthening public information delivery and services.
For the Phase 2, scheduled from 2020-2021, the FDA will address new ways to accelerate growth with a focus on globalization. It involves entering inter-agency partnerships.
“We have to start our digital enforcement activities, improve our laboratory capabilities and improve the FDA Academy service portfolio,” she outlined.
Apart from the 5-year plan, FDA is also looking to modernize its facilities in the main office to “further speed up response and turnaround time for FDA services to its stakeholders and the public.
A planned regional FDA office building in Leyte, which is in Region 8, is also forthcoming.
The regulatory agency is likewise signaling a need to increase its plantilla manpower to provide service in all its plans and programmes.
“All these are in the pipeline as the FDA works in its 54th year to achieve our vision to become an internationally recognized Center of Excellence in health product regulation by 2026,” added Director Puno. MIMS
Ted Stanley: The man behind the Fentanyl lollipop
US doctor ordered to stop marketing three-parent baby technique
3D printing pharmaceuticals: Is this the future?
PH FDA bares 5-year development plan
Martina C, 25 Aug 2017