So much regulatory change!

I was out of the office from late June until 10 August due to a mixture of delivering training and vacation to re-unite with my children and grandchildren post COVID lockdowns.?During this six week period I was staggered at how much regulatory change occurred, which I would usually post on LinkedIn.

Since returning I have been catching up with all of the changes but, unfortunately, I don’t have time to retrospectively post it all here.?You can, however, read about it on the free NSF Pharma app in the ‘What’s New’ section and I will be covering all of the changes and more in the September edition of my virtual Pharmaceutical Legislation Update subscription service (see https://www.nsf.org/training/series/pharmaceutical-legislation-update-subscription )

The changes that have happened over the past 8 weeks are as follows:

In the EU:

·????????EMA Draft ‘Guideline on Computerised Systems and Electronic Data in Clinical Trials’

·????????EMA final version of 'Guideline on Quality Documentation for Medicinal Products When Used With a Medical Device'

·????????EMA Reflection Paper on GMP and Marketing Authorisation Holders

In the UK:

·????????MHRA 20% staff cut

·????????MHRA consultation on Point of Care (POC) manufacturing

·????????MHRA blog on Transfer of Analytical Methods

·????????MHRA update of their Guide to Defective Medicinal Products

Internationally:

·????????Draft of ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products

·????????PIC/S Guide on Evaluating the Effectiveness of Change Management in a PQS

·????????PIC/S Guideline for Inspectors on “Good Practices for Data Management and Integrity in GMP/GDP Environments”

·????????PIC/S Guidance "COVID-19 Risk Assessment for National Routine On-Site Inspections"