CIRS Agenda_2015

Global Development Programme Research

Assessing Hurdles and Enablers of Regulatory Performance

In 2010-2011, CIRS conducted a study to identify best practices in terms of activities, process and procedures, which if adopted by an agency would enable the review process in terms of timeliness, predictability, transparency and good quality. Thirteen companies and thirteen agencies took part in the survey, rating attributes from the following parameters: Guidance/Regulations, Dialogue/Interactions, Transparency, User fees, Submission methods, Management systems, Training, Negotiation of document timing and Other review process attributes.  Attributes were rated from 1 to 5, with 1 representing a barrier to good review practice (GRevP) ; 2, a neutral factor for GRevP; 3, an undetermined factor for GRevP; 4, an enabler of GRevP of low value; and 5, an extremely valuable enabler for GRevP. The most notable discrepancies between company and agency viewpoints were those regarding the importance of dialogue and the ability to negotiate Certificate of Pharmaceutical Product submission timing (Figure 1)

Enablers Fig1

Figure 1. Company and agency viewpoints on attributes that enable regulatory review.

In the second section of the survey, respondents were asked to rate specific regulatory agencies for  attributes that enable GRevP (transparency, timeliness, predictability, quality) from 1 to 5, with 1 being unsatisfactory; 2, poor; 3, satisfactory or fit for purpose; 4, good; and 5, excellent.  For instances in which a lower score was given (1-3) respondents were asked to specify which elements of the attribute needed to be improved, whist if a higher score was supplied (4-5), respondents were asked which of the elements of this attribute could be encouraged for use by other regulatory agencies (Figure 2). Agencies were asked to rate the multinational and local companies on the quality of the dossier submission (Figure 3 ).

Enablers Fig2

Figure 2. Companies indicated areas in which agencies excelled and recommendations for approval.

Enablers Fig3

Figure 3. Agencies indicated their rationales for dossier evaluations.