medicines-medical devices-regulatory affairs
On 3 September 2025, FDA’s CDER and CBER proposed a new process under Rare Disease Evidence Principles (RDEP) to facilitate the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need and with…
Last updated: 9 May 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is…
Last updated: 13 May 2025 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales…
Last updated: 9 April 2025 To view updates, click on the ‘+’ sign below: The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
The table below details changes to five guidance documents (listed in column 1 below) for the authorisation of human medicinal products. Updated guidance document Document (plus form where applicable) What the document concerns Changes to the document Sections of the…
The UK MHRA has announced today that new regulatory recognition routes for medicines will be established using approvals from the following countries: This means that patients will have access to safe and effective medicines that have been approved by trusted…
Health Canada has updated guidances concerning pre and post-licensing submissions and performance standards for PDCs for prescription pharmaceutical drugs and those administered or obtained through a health professional. Notice: Revision to the Guidance Document Management of Drug Submissions and Applications…