medicines-medical devices-regulatory affairs
Health Canada is consulting on proposed Agile regulations and guidance for licensing drugs and medical devices. It is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to…
The TGA is conducting a follow-up consultation on the repurposing of medcines. What is repurposing? TGA defines repurposing of medicines as the process of identifying potential new therapeutic uses (or ‘indications’) for older medicines through new research and evidence. This…
The TGA, Australia is consulting on a proposed priority pathway for assessment of certain novel and life-saving biologicals. Who is the consultation for? The consultation is for consumers, healthcare professionals and the industry. What is the purpose of the consultation? The…
Last updated: 16 August 2023 See updates at the end of the post. The MHRA has launched a consultation on the UK clinical trials legislation. It is consulting on a set of far-reaching proposals to improve and strengthen the UK…
The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…
Health Canada is consulting on revised guidance of Post-Notice of Compliance (NOC) Changes – Quality. Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality have been released for stakeholder consultation. Who is the focus of the consultation?…
The TGA is consulting on proposed refinements to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin. Events leading to this consultation In early 2019, the TGA conducted…
The TGA, Australia, is consulting on proposed refinements to the regulation of personalised medical devices. On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are…
Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs). Why is Health Canada consulting on this policy? Health Canada is updating its policy on DDCPs to provide more detail and clarity…