FDA Circular No. 2014-003 || Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form

Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form

 1.Rationale

Republic Act no.9485, the Anti-Red Tape Act of 2007, was enacted to improve efficiency in the delivery of government services and to establish effective practices aimed at the prevention of graft and corruption in government. Government agencies and offices are mandated to promote transparency with regard to the manner of transacting with the public. Further, these measures shall encompass a program for the adoption of procedures to reduce red tape and expedite transactions in government. Section 5 of the same lawstates that all offices and agencies which provide frontline services shall undergo evaluation and improvement of their transaction systems and procedures and re-engineer the same if deemed necessary to reduce bureaucratic red tape and processing time.

Section 3 of Republic Act no. 9711, 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...". Section 5 of the same law amending Section 4 of Republic Act no. 3720 provided the FDA with the authority "to prescribe standards, guidelines, and regulations with respect to information, advertisements, and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act;".

 

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