Consultation on the International Council for Harmonisation (ICH) M14 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) 🇪🇺 Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Guideline on the content, management and archiving of the clinical master file (paper and/or electronic) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration on the issuance of medical device business quality management standard on-site inspection guidelines notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2024-10001 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 30, 2024 Other (Public Domain) 0 reuses 0 favorites
Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/EWP/89249/2004 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144533/2009 rev 1) Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/1089/00 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human plasma derived von Willebrand factor products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/220/02 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/BPWP/410415/2011 Rev 1 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/94033/2007 rev. 2 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/575/99 Rev. 1 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for finished products - information and data to be provided in regulatory submissions From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on plastic immediate packaging materials From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/QWP/4359/03, EMEA/CVMP/205/04 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/83812/2013 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/5072766/2021 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH harmonised guideline - Nonclinical safety testing in support of development of paediatric pharmaceuticals From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline- ICH S11 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH S1B(R1); EMA/774371/2022 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH guideline Q3D (R2) on elemental impurities From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH Q3D (R2); EMA/CHMP/ICH/353369/2013 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH guideline Q3C (R8) on impurities: guideline for residual solvents From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.* Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites