No. | (Sub-)Indicator | ML |
---|---|---|
CT01 Legal provisions, regulations and guidelines required to define regulatory framework of clinical trials oversight. | ||
CT01.01 | Legal provisions and regulations for clinical trials (CTs) oversight exist. | 1 |
CT01.05 | There are legal provisions or regulations covering circumstances in which the routine CT evaluation procedures may not be followed (e.g. for public-health interests) | 2 |
CT01.11 | Legal provisions / regulations allow NRAs to recognize and use relevant CT decisions, reports or information from other NRAs or from regional and international bodies. | 1 |
CT04 Procedures established and implemented to perform clinical trials oversight. | ||
CT04.07 | The same policies are used for the evaluation of CT applications regardless of the applicant (e.g., domestic, foreign, public sector, or private sector) | 3 |
CT06 Mechanism in place to monitor regulatory performance and output. | ||
CT06.04 | There are timelines for the assessment of CT applications and an internal tracking system to follow the targeted time frames | 3 |