Filing and Submission of Applications for the Approval of Clinical Trial Protocol, Compassionate Special Permit (CSP), Import Permit for Investigational Drug Products, Pharmacovigilance, Adverse Events/Adverse Reaction Reports, and Other Related Documents

I. Rationale

Republic Act 9711 otherwise known as the Food and Drug Act of 2009 empowers the FDA to develop and issue policies, guidelines and regulations that cover establishments,facilities and health products.

Under Republic Act 9485 or the Anti-Red Tape Act of 2007, all government agencies and offices providing frontline services are mandated to regularly undergo evaluation and improvement of their transaction systems and procedures.

II. Objectives

In consonance with the regulatory reforms implemented by the FDA to improve efficiency and quality of services rendered, this guidelines is issued to prescribe/establish the procedure in filing and submission of applications for Clinical Trial Protocol approval, Compassionate Special Permit, Import Permit for Investigational Drug Products and other related documents.  Adoption and implementation of this guidelines seek to provide a simplified, transparent and convenient procedure to all concerned industry partners.

 

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