【英文原文】 The draft Guidance for Industry on “ANDA Submissions – Refuse-to- Receive Standards” states at lines 103 to 109 that in the case of an ANDA with fewer than ten minor deficiencies, FDA will notify the applicant of these deficiencies by phone, e-mail, or fax. The applicant then has a time limit of five (5) business days to satisfactorily amend the ANDA to correct the deficiencies. The draft Guidance proposes that if the requested information is not submitted within the five business day time limit, FDA will refuse to receive the ANDA.
The imposition of a “five business day” time limit in place of the previous ten business day time limit will seriously adversely affect foreign ANDA sponsors. In the case of foreign sponsors, FDA notifies the sponsor’s US Agent of the deficiencies, who in turn then notifies the sponsor. Time differences between the US and, for example, China are such that there is no overlap in business hours. So each cycle of communication takes two business days to process. For example if the US Agent for a foreign sponsor is notified of several (but less than 10) minor deficiencies in an ANDA undergoing acceptance review on a Monday, the Agent then sends notification to the Sponsor which is first seen during business hours on Tuesday. If the sponsor requires clarification of one or more deficiency points, they ask for clarification from their US Agent. Assuming the Agent can immediately provide clarification, the response is first seen by the sponsor during business hours on Wednesday. If any of the deficiencies raised require, for example, reissue of a DMF Reference Letter from a US based supplier, the same two day communication cycle occurs. As a result of time/day differences between the US and, for example, China, even the most diligent sponsors will not be able to meet the five business day time limit in many instances. This is not a result of failure to act as quickly as possible to correct the deficiencies, but rather the result of the time/day differences between the parties involved. Note that the draft Guidance already recognizes the effect of global time differences on communication between FDA and foreign sponsors at lines 180 to 182 describing such communication as “challenging”.
For these reasons we respectfully request that a time limit for response to fewer than 10 minor deficiencies be ten business days, and not the proposed five business days. An acceptable alternative would be to allow foreign ANDA sponsors ten business days to respond to minor deficiencies.
