Guideline on the content, management and archiving of the clinical master file (paper and/or electronic) From Therapeutic Goods Administration (TGA) π¦πΊ 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
Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells From Therapeutic Goods Administration (TGA) π¦πΊ Guide for manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells. 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Master Files Part III - Guidance on Scientific and Technical Information From Food and Drug Administration (FDA) πΊπΈ Master Files Part III - Guidance on Scientific and Technical Information" is a premarket guidance document. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
GN-03-R3 Guidance on Preparation of a Site Master File for Licensing From Health Sciences Authority (HSA) πΈπ¬ Provides detailed instructions on creating a site master file for licensing purposes. Metadata quality: Metadata quality: Data description empty Files documentation missing 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: 44.44444444444444/100 Updated on March 17, 2024 Other (Public Domain) 0 reuses 0 favorites
Regulatory Information From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ A document discussing regulatory information related to reviews and related services. 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 April 13, 2024 Other (Public Domain) 0 reuses 0 favorites
Consultations From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PMDA consultations. 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 May 30, 2024 Other (Public Domain) 0 reuses 0 favorites