40
Q12: Technical and Regulatory Factors for Life Cycle Management of Pharmaceuticals
Provisional implementation
20-113699-873
For more information, please see the Notice page dated October 9, 2020.
Q12: Pilot programs
Avis
21-115313-479
s.o.
E8(R1): General Considerations for Clinical Studies
Step 4 – Final guideline
21-121043-747
This guidance document was implemented on January 14, 2022
E14/S7B: Questions and answers – clinical and non-clinical evaluation of QT/QTc interval prolongation and proarrhythmic effect
Step 4 – Final Questions and Answers Document
22-105019-395
This Q&A document was implemented on June 10, 2022
Q3D(R2): Revision of Q3D(R1) for dermal and transdermal products
Step 4 – Final guideline
22-105313-723
This guidance document was implemented on August 29, 2022
Q3D(R2): Health Canada Advisory
Avis
22-105313-723
s.o.
M10: Validation of Bioanalytical Methods and Analysis of Study Samples
Step 4 – Final guideline
22-108195-929
This guidance document was implemented on January 20, 2023
M10: Questions and Answers – Validation of Bioanalytical Methods and Analysis of Study Samples
Step 4 – Final Questions and Answers Document
22-108195-929
This Q&A document was implemented on January 20, 2023
S1B(R1): Carcinogenicity Testing of Pharmaceuticals
Step 4 – Final guideline
23-102720-154
This guidance document was implemented on June 20, 2023
S1B(R1): Health Canada advisory
Avis
23-102720-154
s.o.
S12: Non-Clinical Biodistribution Considerations for Gene Therapy Products
Step 4 – Final guideline
23-105640-963
This guidance document was implemented on July 21, 2023
2022-07-21 19:50:25
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