Guidance on management of drug submissions and applications: Performance standards

Performance standards for pharmaceuticals, biologics and radiopharmaceuticals

The Office of Submissions and Intellectual Property (OSIP) has 10 days to process submissions or applications (except CTAs and CTA-As) before they are accepted into screening 1 and screening 2 review periods.

Submission		Performance standards (in calendar days)
Type	Class	Screening 1 (including response to NOD)	Review 1 (including response to NOD)	CR review^{Footnote 1}	Screening 2 response to NON	Review 2 response to NON	Review of response to NOC/c-QN
CTA CTA-A^{Footnote 2}	1. Phase I - bioequivalence	7 (administrative target) 30 (default)		N/A	N/A	N/A	N/A
CTA CTA-A^{Footnote 2}	2. All other Phase I, Phase II, Phase III	30 (default)		N/A	N/A	N/A	N/A
NDS SNDS ANDS SANDS EUNDS^{Footnote 2} EUSNDS^{Footnote 2} EUANDS^{Footnote 2} EUSANDS^{Footnote 2} For NDS-D and SNDS-D disinfectants, refer to the next section	1. Priority - NAS, Clin or Non Clin data and C&M, Clin or Non Clin data only	25	180	300	25	90	0
	2. NOC/c - NAS, Clin or Non Clin data and C&M, or Clin or Non Clin data only	25	200	300	25	90	30
	3. PHED - NAS, Clin or Non Clin data and C&M, or Clin or Non Clin data only, C&M only, Labelling only, Administrative, NC quality (biologics only)	Performance standards of the applicable submission class apply but may be accelerated^{Footnote 3}
	4. NAS	45	300	300	45	150	0
	5. Clin or Non Clin data and C&M	45	300	300	45	150	0
	6. Clin or Non Clin data only	45	300	300	45	150	0
	7. Clin or Non Clin data only, in support of safety updates to the labelling (SNDS/SANDS only)	25	120	120	7	75	0
	8. Comp data and C&M or Comp data only	45	180	180	45	150	0
	9. C&M data only	45	180	180	45	150	0
	10. Labelling only	45	120	120	45	75	0
	11. Labelling only (generic) (SNDS/SANDS only)	45	120	120	45	75	0
	12. Administrative	45 Administrative screening		45	0	0	0
DINA, DINB (For DIND disinfectants, refer to the next section)	1. Labelling standard	60	60	0	0	0	0
	2. Clin or Non Clin data and C&M	45	210	210	45	150	0
	3. Clin or Non Clin data only	45	210	210	45	150	0
	4. Comp data and C&M or Comp data only	45	210	210	45	150	0
	5. C&M data only	45	210	210	45	150	0
	6. Labelling only	45	120	120	45	75	0
	7. Administrative	45 Administrative screening		45	0	0	0
DINF	1. Labelling standard	60		60	0	0	0
DINF	2. Administrative	45 Administrative screening		45	0	0	0
NC^{Footnote 2}	1. NC quality (90 day) for biologics and radiopharmaceuticals	7	90	N/A	0	0	0
PDC^{Footnote 2}	1. Post-authorization Division 1 change for non-prescription pharmaceuticals	30		N/A	0	0	0
	2. Post-authorization Division 1 safety change for prescription pharmaceuticals	25	120	N/A	N/A	N/A	N/A
	3. Post-authorization Division 1 quality change for prescription pharmaceuticals	25	90	N/A	N/A	N/A	N/A
	4. Administrative	45 Administrative screening		N/A	0	0	0
PDC-B^{Footnote 2}	1. Post-authorization Division 1 change (biologics)	45	210	N/A	45	150	0
PDC-B^{Footnote 2}	2. Administrative	45 Administrative Screening		N/A	0	0	0
Table 1 footnotes Footnote 1 The cost recovery (CR) review column defines the applicable performance standard associated with each activity and fee as per the performance standards for the Fees in Respect of Drugs and Medical Devices Order. The performance standard is the period from the date of acceptance to date of first decision not including any review clock pauses. If a drug submission (not including combination products or those subject to a joint or parallel foreign review) is not reviewed within the established CR performance standard, sponsors are credited 25% of the original fee. Return to footnote 1 referrer Footnote 2 Non cost-recovered submissions and applications Return to footnote 2 referrer Footnote 3 Submissions for PHED are not subject to fee remission in the case of a rolling review. Return to footnote 3 referrer

For interpretation of performance standards, refer to the glossary and terminology sections.

Performance standards for disinfectants

For more information on disinfectants, consult:

Guidance documents on disinfectantss

Submission		Performance standards (in calendar days)
Type	Class	Screening 1 (including response to NOD)	Review 1 (including response to NOD)	CR review^{Footnote 1}	Screening 2 response to NON	Review 2 response to NON	Review of response to NOC/c-QN
NDS SNDS	1. Clin or Non Clin data and C&M	45	300	300	45	150	30
	2. Clin or Non Clin data only	45	300	300	45	150	30
	3. Clinical or non-clinical data only, in support of safety updates to the labelling	45	90	90	45	60	0
	4. C&M data only	45	300	300	45	150	0
	5. Labelling only	45	90	90	45	60	0
	6. Administrative	45 Administrative screening		45	0	0	0
DIND	1. Labelling standard	60		60	0	0	0
	2. Clin or Non Clin data and C&M	45	210	210	45	150	0
	3. Clin or Non Clin data only	45	210	210	45	150	0
	4. C&M data only	45	210	210	45	150	0
	5. Labelling only	45	90	90	45	60	0
	6. Administrative	45 Administrative screening		45	0	0	0
PDC^{Footnote 2}	1. Post-authorization Division 1 change (disinfectants)	30		N/A	0	0	0
PDC^{Footnote 2}	2. Administrative	45 Administrative screening		N/A	0	0	0
Table 2 footnotes Footnote 1 The cost recovery (CR) review column defines the applicable performance standard associated with each activity and fee as per the performance standards for the Fees in Respect of Drugs and Medical Devices Order. The performance standard is the period from the date of acceptance to date of first decision, not including any review clock pauses. If a drug submission (not including combination products or those subject to a joint or parallel foreign review) is not reviewed within the established CR performance standard, sponsors are credited 25% of the original fee. Return to footnote 1 referrer Footnote 2 Non cost-recovered submissions and applications Return to footnote 2 referrer

For an interpretation of performance standards, refer to the glossary and terminology sections.

Consult the Guidance on evaluation fees for human drugs and disinfectants.

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2025-10-01

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Guidance on management of drug submissions and applications: Performance standards

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Performance standards for pharmaceuticals, biologics and radiopharmaceuticals

Table 1 footnotes

Performance standards for disinfectants

Table 2 footnotes

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