FDA Circular No. 2017-004

Reiteration of the Rule on Licensing Application Requiring Prior Inspection Pursuant to Administrative Order No. 2016-0003 dated February 15, 2017

I. INTRODUCTION

Section 3 of Republic Act No. 9711 or Otherwise known as the Food and Drug Administration Act of 2009, has declared it a policy of the State to adopt, support, establish, institutionalize, improve, and maintain structures, processes, mechanisms, and initiatives that are aimed, directed, and designed to help establish and maintain an effective health products regulatory system.

Republic act No. 9485 or otherwise known as the Anti-Red Tape Act of 2007 was enacted to improved efficiency in the delivery of government services and to establish effective practices aimed at the prevention of graft and corruption in the government. Section 5 thereof expressly mandates all offices and agencies which provide frontline services to regularly undergo evaluation and improvement of their transaction systems and procedures and re-engineer the same if deemed necessay to reduce bureaucratic red tape and processing time.

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