UK MHRA Seek Medicines Pipeline Data

Date

October 15, 2024

Category

UK Regulations

Description

The UK MHRA are requesting that current or potential medicines Marketing Authorisation Holders (MAH) provide information on planned or potential future submissions to them.

MHRA has provided a spreadsheet template that contains a number of fields to be filled in about expected and possible submission of applications and variations to the MHRA. It is intended that we build a picture of all incoming applications and new indications up to 5 years in advance of submission.

Examples of data fields requested:

• Product Name
• Active Ingredient
• Product type (e.g. Chemical, Biological, Monoclonal Antibody)
• Indication
• Year/Quarter/Month expected submission date
• Expected submission route
• Additional MHRA services required (e.g. ILAP, Scientific Advice)

Details can be found at https://www.gov.uk/guidance/medicines-pipeline-data