Table 2.

Perceived hurdles when using reliance

	% of positive responses	Number of responses
Additional administrative requirements/documents including local M1 and other local documents	66%	27
Unredacted assessment report	54%	22
No clear reliance guideline or reliance not practiced	51%	21
Strict interpretation of product sameness	44%	18
No regulatory framework allowing reliance	41%	17
No Confidentiality Agreement or Memorandum of Understanding between reference authority and relying authority	34%	14
No clear understanding of reliance definition or no acceleration of timelines	24%	10
Not enough Reference Authorities to apply reliance or restricted scope	17%	7
Long submission lag time	15%	6
Difficulties in accepting eCPP	7%	3
None of the above or other	2%	1