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With less than six months to go before the Brexit transition period expires, European regulatory authorities have warned sponsors of clinical trials in the EU that the qualified person for batch release of investigational medicinal products (IMPs) must be based in the EU from 1 January 2021, otherwise there could be a risk to the safety of trial participants.

The deadline for the UK to request an extension to the transition period was the end of June, and the UK government did not make any such request. This means “there is no possibility for further extension” beyond 31 December, says a technical notice issued by the European Commission, the European Medicines Agency and the Heads of Medicines Agencies.

Observing that the UK is now a “third country” following its departure from the EU at the end of January, the notice says that sponsors of trials in EU member states should be aware that after the end of the transition period, IMPs used in trials can only be imported once their batch release has been certified by a qualified person (QP) in the EU, and that this can no longer be done by a QP in the UK.

It seems that not all sponsors have taken steps to ensure this is the case. As of 1 July 2020, based on data registered in the European Clinical Trials database (EudraCT), it says, “there are 250 clinical trials where the QP is established in the UK and which have been authorized in at least one EU member state other than the UK within the last 3 years (since 30 June, 2017).” There are also about 3,000 other trials with a QP in the UK authorized before this date.

“Sponsors of all ongoing trials need to establish a QP in the EU,” the notice says. “Failure to do so could in the worst case result in discontinuation of trial treatment and thus jeopardize trial participants’ safety.”

It also points out that the sponsor of a clinical trial or their legal representative must be established in the EU if the trial is taking place in one or more EU member states. Again, though, it seems not all sponsors have taken action to ensure this is the case. There are some 200 trials registered in EudraCT where the sponsor itself is established in the UK and the trial has been authorized in at least one member state other than the UK within the past three years (again since June 30, 2017), the notice states. In addition, it says there are some 750 other trials where the sponsor is established in the UK but which had been authorized before that date.

For trials authorized in at least one EU member state where the sponsor is established in a third country and with a legal representative in the UK, the sponsor must establish its legal representative in the EU by the end of this year. “Failure to meet this requirement will be a breach of Directive 2001/20/EC [the clinical trials directive] and could trigger a request for corrective actions by member state competent authorities,” the notice declares.

Directive 2001/20/EC will be repealed and replaced by the new EU Clinical Trial Regulation (No 536/2014), whose provisions are currently forecast to take effect in December 2021 and will therefore not apply to the UK. (Also see "EU Clinical Trials Regulation To Apply From December 2021" - Pink Sheet, 16 Jun, 2020.)

The regulatory authorities also point out that as of March this year, member states can include in EudraCT details of the EU legal representative for clinical trials where the sponsor is established in the UK. After the end of the transition period, EudraCT will be adjusted to enable sponsors to enter details related to the EU legal representative for trials with UK sponsors.

Other Worries

Having to set up an EU presence is just one of the many complications Brexit is bringing to the pharmaceutical sector. Last month, amid concern over the sluggish pace of the negotiations on a future UK-EU trade relationship, and the possibility that a deal might not be reached by the end of 2020, industry bodies called on EU leaders to push for as much cooperation on medicines regulation and trade as possible. (Also see "Industry Presses EU To Agree Medicines Deal With UK" - Pink Sheet, 18 Jun, 2020.) 

Earlier an internal pharmaceutical industry memo had revealed that UK companies had urged the government to build up its own stockpiles of medicines and bring back the emergency freight service planning that had been put in place last year to deal with the possibility of a no-deal Brexit. (Also see "Get Stockpiling Now, Industry Urges UK Government" - Pink Sheet, 8 Jun, 2020.)

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