EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products

Human tissue

After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and planned mitigation is prudent, if not a virtue, but to over anticipate and have no ‘plan B’ can be inspection suicide. Factor in the endless myths and legends that prevail as folklore in the industry, particularly for the FDA, and it is frankly not surprising that I have seen so many ‘rabbits in the headlights’ during inspections – sadly, often more through being caught off guard, than through lack of subject matter expertise. In my own considerable, yet still by no means infinite, experience, the area where inconsistency is most consistent a factor, is human tissue-based products’ regulatory inspections – but more in the context of the inspections of the regulations, rather than the regulations themselves.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.


Free access to selected content

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account

2. Members login

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.



Special offer on
TOPRA membership

Join TOPRA today and get membership until the end of 2025 for the exclusive rate of £290.

In addition to unlimited access to Regulatory Rapporteur content, as a TOPRA member you will also be able to enjoy a wide range of benefits including career boosting resources, savings on our events and training, and access to our regional networks and special interest groups.

This offer ends 31 July 2024

Become a member