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
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency. 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 April 4, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
European medical device regulations From Ministry of Health (Italy) (MDS) 🇮🇹 Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic,… 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 December 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
MDR Newsletter 6/2020: MDR and harmonisation regulations, creation of NeoEMKI From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing MDR and harmonisation regulations, as well as the creation of NeoEMKI in the 6/2020 edition. 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 March 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Draft Health Canada IMDRF table of contents for medical device applications guidance From Health Canada 🇨🇦 The IMDRF is a voluntary group of regulators committed to the acceleration of medical device regulatory harmonization and convergence. 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 September 21, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations (“the Regulations”) amend the Active Implantable Medical Devices Regulations 1992 (“the principal Regulations”) which implement Council Directive 90/385/EEC (OJ No. L 189, 20.7.90, p. 17) (“the active implantable medical devices Directive”). The Regulations implement those… 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 June 30, 1995 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites