| 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 |
