The Philippines FDA Streamlines Amendment Submission Process

On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.

Currently, a single license holder is limited to 5 application submissions per week.  This practice was established so that large license holders would not monopolize CDRRHR resources.

Under the new guidance, qualifying CPR amendment applications can be grouped together in a single submission. For example, a change to the legal manufacturer’s address that applies to 20 CPRs may now be submitted at one time as opposed to over 4 weeks as was previously required.

A copy of Philippines FDA Circular 2017-014 is available at the bottom of the Philippines page of the Asia Actual web site.

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