Clarification on the Provisions of Administrative Order No. 2013-0022, on the Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers
With the recent implementation, in part, of Republic Act No. 9711, otherwise known as the Food and Drug Administration (FDA) Act of 2009, which specifies the establishment of centers by product categories, the Center for Drug Regulation and Research (CDRR) was created.
The provisions of the Department of Health (DOH) Administrative Order No.2013-0022, on the Guidelines For Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers, as signed by the Secretary of Health on August 13, 2013, is hereby clarified:
Download attachments to continue reading.