Increasing Inspection Coverage in the Wake of Globalisation; European Medicines Agency's Fergus Sweeney

Fergus Sweeney

In support of our European activities, the European Medicines Agency (EMA) also has a role in the harmonisation of inspection procedures, and consequently we run clinical  and manufacturing practices and Pharma co-vigilance inspectors’ working groups where all of the national competent authority inspectorates are represented, because EMA itself doesn’t do inspections. We work with the inspectors of the member states to do those.
The EMA has an overall confidentiality arrangement with the Food and Drug Administration (FDA) and the European Commission which has been in place since 2004. One of our main focuses is in the field of inspection, and this is particularly important because of the globalisation, both of manufacturing and the conduct of clinical trials. The idea is to work together and bring together the inspectors of the EU and the FDA to conduct a number of joint inspections so that we can learn each others’ processes and build confidence in the way we operate. Since 2009, in the case of clinical trials, we have had a joint GCP initiative which will actually come to the completion of its 18-month pilot this month - it’s been successful – and we will be issuing a report quite soon.
Harmonisation between the EMA & FDA

Added to this, if the FDA’s doing an inspection in Europe or the Europeans are doing an inspection in the US, the home party comes and watches what’s happening, rather than actively participating. But again, it’s a learning process and the aim is to build confidence in each other’s processes, so that in the future we won’t duplicate inspections and turn up at the same place; we’ll go somewhere else and then we can all share the information. We get greater inspection coverage for the same resource sponsors and investigators aren’t inspected two or three times by different regulators; and hopefully that will increase the coverage and the message from the inspectorates from the US and Europe.
US inspectors are also joining our European training courses, and some European inspectors have been to the US, which means we are beginning to harmonise our approach and our thinking on key issues. We’ve also exchanged draft guidance, they’ve joined discussions in our working groups by teleconference and vice versa, so it’s been a very successful approach, and we have an analogous approach on good manufacturing practice.
Challenge of Globalisation on regulation

Wherever you sit in the world as a regulator, around two thirds of whatever you’re regulating as an end product is either developed in clinical trials or manufactured somewhere else in the world, and that’s going to apply whether you’re sitting in Europe, the US, South America, or from Argentina to China. So it’s a challenge for all regulators. We have to start working together and understanding each other, because whoever oversees the set-up where the trial is run has to ensure that the infrastructure pre-trial is set up, a good framework is in place and that it will be well-regulated. And if we all can build trust, understanding and confidence with the other regulatory systems and help each other with training and harmonise requirements; then that safety of the supply chain or of the conduct of trials can be much better assured.
The Clinical Trial Register
The Clinical Trial Register was set up under the Clinical Trial Directive in Europe in 2004, as a confidential database for communication between the national competent authorities of Europe, the Commission and the Agency on Clinical Trial Oversight, and particularly the authorisation of clinical trials with investigator sites in Europe.
Now, trials in Europe are authorised by the member states – the Agency isn’t directly involved, other than running this database and related safety database, your Divisional Clinical Trial Module. Now, that database was established as a confidential one, but then articles in the regulation establishing EMA were amended and also the paediatric regulation brought in clauses, both of which opened the confidentiality to allow us to put a certain amount of information in the public domain.
We are now able to put a dataset for all clinical trials involving paediatric populations with an investigator site in Europe in the public domain or listed in a paediatric investigation plan (PIP).  All clinical trials in adults, other than purely phase one, can be included so that the large part of trials with investigator sites in Europe are now in the public domain and I think, as of today, there are about 14,800 trials on the register. We’re about two thirds of the way there; we’ve about 21,000 trials already in the system in total that can go into the public domain, and then that will progressively grow as new trials join the system.
Overcoming Teething Problems
I think from the point of view of key challenges, the fact that the database started life as a confidential database and the register is now a public view on some of that data means that the data goes through the national competent authorities into the system, which in one respect is very good, in terms of control, ensuring it’s there, and ensuring the trials are released and public at the time of authorisation. The downside is that, obviously, for each competent authority there would potentially be a lot of maintenance in updating that data so we don’t have the sponsors individually updating their information, which would allow us, for instance, to have the data of enrolment commencing, the date that enrolment finishes and other information updated on a more regular manner because each sponsor in himself has one to 20 trials to update, whereas a national authority might have 500 or 1,000 so it’s a different scale. But I think that’s something we’ll develop. We’ve got plans in next year’s version, starting in the New Year, to open up some of the data maintenance to sponsors, although we have to revise some guidance to allow that, and obviously build the software.
For the registry itself, the key issues are to ensure the data quality going into you direct and therefore the data quality that appears in the public domain, and secondly to improve the ability of the public to find what they’re looking for; so to enhance the search tools, particularly in the areas of linking thesauruses and dictionaries to the search tools so that if somebody, for instance, puts in the word cancer the system will also look for neoplasm and other related terms, possibly also in some other languages. So it’s helping the patient, the healthcare provider or the researcher to find what’s in there, because if we have 21,000 trials you need to have a good search tool to find what you’re looking for.
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