News

July 2021
Real CMC Tips and Insights

published 5 Aug 2021

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in July 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

IMPDs for Small Molecule Drugs

For Phase I studies, stability data on the IMP need not be available at clinical trial application stage. However, the assigned shelf-life must be justified, studies under accelerated and long-term conditions initiated before study start, and an ongoing stability program performed with the relevant batches. For Phase II and III studies, stability data at accelerated and long-term conditions must be submitted for evaluation in the IMPD.

 

When is an Excipient Novel?

A novel excipient is a new or well-established chemical entity being used for the first time in a drug product or by a new route of administration. When determining if an excipient is novel or not, consider use throughout the ICH regions. European competent authorities have been known to regard excipients as non-novel when used extensively in ICH regions other than Europe.

 

EMA Training Materials 

Recordings and/or presentations from EMA workshops are generally available on the EMA website for years following the event, providing a wealth of information and training materials. Some of the CMC-relevant workshops on the website are the ones on biopharmaceuticals, development for paediatric use, ICH Q3D, and many more.

 

Structuring Module 3

A well-structured dossier is so much easier to evaluate. If you wish to facilitate review, list tests in the same order throughout the dossier: in the specifications table, when describing analytical procedures, when justifying specifcations, on COAs, and in the batch analyses and stability tables

 

For previous monthly round-ups, you can follow these links:

June 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3jtMtjb

May 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-2V19DEX

March 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-2SrciXD

February 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3uhFpcU

January 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3qgM2dp

December 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3jlAPGF

November 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3soERlp

October 2020 Real CMC Tips & Insights Round-Up:  https://bit.ly/RealCMC-3kbdPsv

September 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3k2PGEx

August 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-32iYuAd

July 2020 Real CMC Tips & Insights Round-Up:  https://bit.ly/RealCMC-2XCrqk1   

Search Real Regulatory