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We last reviewed government inspections about 2 years ago. There have been some changes and updates making a review worthwhile now. Actually it’s always good to review your company’s inspection status and preparations periodically as a bad inspection will produce headaches for quite some time.  The gift that keeps on giving!



Firstly we must acknowledge the “800 pound gorilla” sitting in the middle of the room: namely Brexit. The current procedure for Good PV Practice (GPvP) is based on the EU requirements. This is noted immediately on the inspection website: “MHRA inspects marketing authorisation holders (MAH) to determine that they comply with pharmacovigilance obligations established within the EU.”

If/when Brexit occurs, it is likely that the procedures will change, as the UK will no longer be subject to EU requirements unless Brexit is delayed or rescinded. Even if this occurs it is highly likely that the procedures in place now will be continued in some form for some time as the inspection process is “not broken” and has been operating satisfactorily for the MHRA for many years.

The MHRA has indicated that vigilance inspections will continue with or without a Brexit deal.  What they have not addressed (at least nothing has been said officially) is the pace of inspections and whether a full contingent of inspectors will be available. It is also unclear how the UK would do inspections in the EU if the UK does indeed leave. The EU would be a “third party” and setting up the inspection will be more complicated. Since companies with registrations (MAs) in the EU will have to register the products in the UK to continue sales in the UK, there will be a longish transition process. For UK inspections, it is likely the local UK MA holder (MAH) would be inspected by the MHRA rather than the MHRA going to the member state where the bulk of the PV work is done.

All of this needs to be worked out and it is likely that the MHRA and the UK inspectorate division will need time to work this out. For practical purposes, companies selling product or doing clinical trials in the UK should be prepared for a PV inspection at any time.

Companies should review their SOPs to be sure that the mechanism to handle an inspection is in place whether Brexit comes through soon or not. Surely, though, there will be changes after Brexit is put into place. As you will see below, the MHRA works with the EMA in preparing the schedule and in conducting the inspection.  This will surely in ways unknown as of now.


MHRA Inspection Website

The MHRA has updated its inspection website several times in the last couple of years. This website should be well-known and periodically reviewed by anyone handling PV in the UK and EU.

The topics are:


The latest published metrics for UK pharmacovigilance inspections show that 22 PV inspections were done from April 2017 to March 2018. Presumably the MHRA relied on inspections done by other EU member states. Whether the MHRA will continue to receive and rely on these reports remains to be seen. Also whether the UK must increase the number of both domestic and ex-UK inspections remains to be seen.

Note: There is a 51 minute webinar recently loaded onto the website describing the technical IT and regulatory issues in electronic submissions to the MHRA including ICSRs and PSURs. The part about PV starts at about 40 minutes.


Bottom Line

As you can readily see from this blog and a review of the MHRA PV inspection website, Brexit has produced enormous uncertainty in the PV inspection system in the UK.  The UK has been doing these inspections for over 15 years and the system is well worked out. Brexit is throwing a monkey wrench/spanner (US usage/UK usage) into system.  At this point we know there will be changes but we do not know when they’ll occur or what they will be.  If there is “no deal” between the UK and EU on Brexit, expect chaos in the short and even mid-term periods.

Likely there will be additional negotiations by the MHRA with the newly-located EMA in Amsterdam though these probably won’t occur for some time since the EMA transition will take many months and possibly years. Changes in PV usually take some time to be prepared, agreed on and implemented.


For All Companies

As noted above, be sure your company has a system and set of SOPs in place to handle any inspection that may occur.  Coordination with your partners, subsidiaries, affiliates, agents, vendors, service providers etc. in the EU and elsewhere must be assured.  Be prepared for inspections from the EU if the EMA chooses not to rely on or work with the post-Brexit MHRA.


For US Companies

If you only sell or study in the US there should be no changes or issues. However, if your US company is international or has vendors or marketing/research partners abroad, particularly in the UK or EU, then they may be touched by these issues and changes. You should be in contact with them to be sure that they are ready for an inspection. If they are inspected you may, of course, be required to provide them data and assistance at short notice. Of course, you are always subject to FDA inspections so your audit and inspection readiness should always be active and in place.


For UK and EU Companies

It’s a new world out there. Both the MHRA and EMA are in transition and will be for at least two years as the EMA is moving into its temporary headquarters now and is due to move into its permanent site in November 2019.  As with any move and IT system change/move there will be many things to iron out. This may mean routine inspections will slow down or be delayed. Alternatively, it is probable that the UK will do non-site inspections by phone, internet, etc. Perhaps more than before. Top priority or for cause inspections will continue.  Unless arrangements are made, it is likely the EMA inspections will not include EU personnel. Similarly with the EMA, changes will have to be made as much of EMA’s work was done by the MHRA and that will stop. Inspectors may not come from the UK any longer. This may mean native English speakers will be fewer (As Malta and Ireland will be the only countries with native English speakers). What impact this will have remains to be seen.


So for everybody, the same bottom line: be ready for inspections come what may!

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