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ICH E6(R3) Module 1 Training Now Available on the ICH Website

Lat0k2025-10-08T00:00:00+00:00octubre 8th, 2025|0 Comments

The ICH Secretariat is pleased to announce the publication of the following training module, now available in the ICH Training Library: Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline - Module 1: Introduction [...]

The ICH E2D(R1) Guideline reaches Step 4 of the ICH Process

Lat0k2025-09-24T00:00:00+00:00septiembre 24th, 2025|0 Comments

The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now [...]

PAR update (December 2009)

Lat0k2025-09-19T21:45:09+00:00septiembre 19th, 2025|0 Comments

PAR update (January 2016)

ICH Q3E Step 2 Presentation Now Available on the ICH Website

Lat0k2025-09-18T00:00:00+00:00septiembre 18th, 2025|0 Comments

In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.

ICH E11A EWG Training Material Now Available on the ICH Website

Lat0k2025-09-18T00:00:00+00:00septiembre 18th, 2025|0 Comments

The ICH Secretariat is pleased to announce the release of E11A Pediatric Extrapolation Training Module 1 - Case Example: Development of a hypothetical TNF-alpha inhibitor "Drug X" for the treatment of polyarticular juvenile idiopathic arthritis [...]

HavrixEnd of procedure:…

Lat0k2025-09-15T07:45:11+00:00septiembre 15th, 2025|0 Comments

HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025

Pheniramine maleate, naphazoline…

Lat0k2025-09-15T07:45:11+00:00septiembre 15th, 2025|0 Comments

Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date of publication: 25/09/2025

2025, Q1-Q2 – Statistics for New…

Lat0k2025-09-15T07:45:11+00:00septiembre 15th, 2025|0 Comments

2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

The ICH M14 Guideline reaches Step 4 of the ICH Process

Lat0k2025-09-12T00:00:00+00:00septiembre 12th, 2025|0 Comments

The ICH M14 Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines” has reached Step 4 of the ICH Process on 04 September [...]

Member: Helen VellaAlternate:…

Lat0k2025-09-05T20:45:16+00:00septiembre 5th, 2025|0 Comments

Member: Helen VellaAlternate: Paula Cardona Xuereb Awtorità dwar il-MediċiniSir Temi Zammit BuildingsMalta Life Sciences ParkMT-SGN 3000 San Gwann

Member: Andrzej…

Lat0k2025-09-04T20:41:40+00:00septiembre 4th, 2025|0 Comments

Member: Andrzej CzeslawskiAlternate: Pawel Pawlowski Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181CPL-02-222 Warszawa

Member: Marta…

Lat0k2025-09-03T20:34:41+00:00septiembre 3rd, 2025|0 Comments

Member: Marta Marcelino Alternate: Rui Pedro da Costa Vilar INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA

Member: Christin…

Lat0k2025-09-02T20:32:35+00:00septiembre 2nd, 2025|0 Comments

Member: Christin OlofssonAlternate: Adam Andersson Medical Products AgencyDag Hammarskjölds väg 42SE-751237 UPPSALA

Member: Vlasta Zavadova Office of…

Lat0k2025-09-01T20:31:39+00:00septiembre 1st, 2025|0 Comments

Member: Vlasta Zavadova Office of HealthÄulestrasse 51LI-9490 Vaduz

ICH Q3E Draft Guideline is Available Now on the ICH Website

Lat0k2025-08-07T00:00:00+00:00agosto 7th, 2025|0 Comments

The ICH Q3E draft “Guideline for Extractables and Leachables” and supporting document has reached Step 2b of the ICH Process on 1 August 2025 and entered the Step 3 public consultation period.