ICH M12 on drug interaction studies - Scientific guideline
Submitted by Anonymous (not verified) on 23 May 2025 - 13:28
ICH M12 on drug interaction studies - Scientific guideline
Overview of comments received on ICH E6(R3) guideline for good clinical practice – Annex 2 - Step 2b
Submitted by Anonymous (not verified) on 23 May 2025 - 13:22
Overview of comments received on ICH E6(R3) guideline for good clinical practice – Annex 2 - Step 2b
ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
Submitted by Anonymous (not verified) on 23 May 2025 - 13:20
ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
Overview of comments received on ICH M11 technical specification during second consultation (EMA/CHMP/ICH/778800/2022)
Submitted by Anonymous (not verified) on 23 May 2025 - 13:17
Overview of comments received on ICH M11 technical specification during second consultation (EMA/CHMP/ICH/778800/2022)
Consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets - Scientific guideline
Submitted by Anonymous (not verified) on 23 May 2025 - 12:48
Consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets - Scientific guideline
Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets
Submitted by Anonymous (not verified) on 23 May 2025 - 12:44
Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets
Changes to the use of antibiotic azithromycin
Submitted by Anonymous (not verified) on 23 May 2025 - 11:01
Changes to the use of antibiotic azithromycin
EMA starts review of ipidacrine-containing medicines
Submitted by Anonymous (not verified) on 23 May 2025 - 11:01
EMA starts review of ipidacrine-containing medicines
Referral: Azithromycin-containing medicinal products for systemic use, azithromycin Article 31 referrals CHMP opinion, 22/05/2025, 23/05/2025
Submitted by Anonymous (not verified) on 23 May 2025 - 11:01
Referral: Azithromycin-containing medicinal products for systemic use, azithromycin Article 31 referrals CHMP opinion, 22/05/2025, 23/05/2025
Human medicines European public assessment report (EPAR): Teriparatide Ascend, teriparatide, Status: Application withdrawn
Submitted by Anonymous (not verified) on 23 May 2025 - 11:00
Human medicines European public assessment report (EPAR): Teriparatide Ascend, teriparatide, Status: Application withdrawn