Safety information From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Safety information from the French Agency for the Safety of Medicines and Health Products Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency 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 today Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices Metadata quality: Metadata quality: Data description filled 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: 55.55555555555556/100 Updated 1 week ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-19722. The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
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 Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to use the procedure for medicines licensing applications. 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 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Pre-submission Advice & Support From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. 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 August 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document by the FDA on the regulation of complementary and alternative medicine products, covering administrative and premarket topics. 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Application to amend the Poisons Standard From Therapeutic Goods Administration (TGA) 🇦🇺 Scheduling of medicines. 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 August 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Register medical devices to place on the market From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland 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 August 2, 2024 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
Transparency for machine learning-enabled medical devices: Guiding principles From Health Canada 🇨🇦 Guiding principles for good medical device machine learning practice developed by Health Canada, the US Food and Drug Administration and the United Kingdom’s 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 July 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Report an adverse event or problem (industry) From Therapeutic Goods Administration (TGA) 🇦🇺 As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Report an adverse event or problem (health professionals) From Therapeutic Goods Administration (TGA) 🇦🇺 Report an adverse event or problem related to a medicine, vaccine or medical device as a health professional. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Provisional approval pathway From Therapeutic Goods Administration (TGA) 🇦🇺 Information on how to register a prescription medicine under the provisional approval pathway. 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 June 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Priority review pathway From Therapeutic Goods Administration (TGA) 🇦🇺 The priority pathway provides a formal mechanism for faster assessment of vital and life saving prescription 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 on June 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices From European Parliament 🇪🇺 A draft implementing regulation detailing procedural rules for cooperation among Member State Coordination Group, Commission, and European Medicines Agency on joint clinical assessments and scientific consultations for medicinal products and medical devices. 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 26, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Submissions received: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
D-glucose, polymer with xylitol From Therapeutic Goods Administration (TGA) 🇦🇺 Compositional Guideline for D-glucose, polymer with xylitol permitted for use in listed medicines. 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 June 14, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Bacillus subtilis strain NRRL B-67989 From Therapeutic Goods Administration (TGA) 🇦🇺 Compositional Guideline for Bacillus subtilis strain NRRL B-67989 permitted for use in listed 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 on June 14, 2024 Other (Non-Commercial) 0 reuses 0 favorites