New Innovative Licensing and Access Pathway (ILAP)
Last updated: 27 April 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in a in an easy…
Pharmavibes
medicines-medical devices-regulatory affairs
Category Medicines Licensing
Read MoreNew Innovative Licensing and Access Pathway (ILAP)
New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service
Last updated: 14 April 2026 To view updates, click on the ‘+’ sign below: On 1 April 2026, the MHRA and NICE launched an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines…
UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough therapies in high-impact areas
Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…
New FDA process to facilitate approval of drugs to treat rare diseases in very small patient populations
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…
Marketing authorisation routes for medicines in the UK
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…
MHRA guidance on the International Recognition Procedure (IRP)
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…
MHRA to relaunch the Innovative Licensing and Access Pathway (ILAP) pathway in Q1 2025
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 MHRA guidance on the assessment of established medicines in order to help applicants and shorten time frames
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…
Swissmedic – changes to various guidance documents for the authorisation of human medicinal products
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…
MHRA announces new regulatory recognition routes for medicines licensing using approvals from various countries
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…