So much regulatory change!

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"

Chiemezie N.

Pharma Quality Professional | EU Qualified Person-ATMP | Biologics | IMP

3 年

Thanks Peter Gough for sharing. I find the NSF app very useful with these updates.

Hung D.

Ensuring Patient Safety & Pharmaceutical Quality @ U.S. FDA

3 年

Thanks Peter, welcome back to LinkedIn.

Barry J Oliver

VP Quality, Global Cell, Gene & Protein Therapies (DS/DP) & BioAnalytics

3 年

Thanks Pete, fantastic updates as always ????

Garth N.

BioPharma Quality Professional | Pharmacist | QP | MBA

3 年

Thanks, Pete for sharing! It's the only Linkedin post I always look forward to reading.

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