IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18


Inside this issue


EMA cuts operations as Brexit staff losses exceed expectations

The EMA is temporarily scaling back its activities in order to accommodate higher-than-expected staff attrition ahead of its move from London to Amsterdam.

The agency says the suspension of some non-urgent activities will allow it to keep essential services running as it faces the loss of around a third of its headcount.

“It has become clear that the agency will lose more staff than initially anticipated,” said the EMA in a statement, adding that “this trend is expected to accelerate” as the date for the relocation approaches. It’s also concerned about the situation after the move, saying there is a “high degree of uncertainty on mid-term staff retention.”

From 1 October, the EMA will reduce international collaborations in order to focus on critical areas such as product evaluation and supervision and supply-chain integrity. It will take a reactive stance on less urgent matters such as harmonisation and antimicrobial resistance, which will be considered on a case-by-case basis.

Guidelines development will also be confined to urgent areas, such as Brexit itself or public health emergencies, and non-essential working party activities will be curtailed. The agency says it also will not attend stakeholder meetings that are not related to Brexit or the agency’s relocation.

The EMA is moving to its new location next year as a consequence of the UK’s exit from the EU, which takes place on 29 March 2019. The final home for the agency won’t be ready for some months, however, and staff will initially occupy temporary premises in the city.

The reduced activities will help maintain essential public health activities and “allows for training of EMA staff who will be re-assigned to new duties ahead of the peak relocation time which will start in early 2019,” according to the regulator.

Meanwhile, the UK has formally requested to remain a part of the EMA in the much-anticipated white paper published by Theresa May’s government in June that set out the proposed terms of the future relationship between the UK and EU.

The aspiration, however, is somewhat lacking in detail, with the UK suggesting that the Medicines & Healthcare products Regulatory Agency (MHRA) should remain an “active participant” in the EMA and still able to “conduct technical work, including acting as a ‘leading authority’ for the assessment of medicines, and participating in other activities like ongoing safety monitoring and the incoming clinical trials framework.”

Brexit talks have resumed, but with just a few months to go there have been warnings from both the UK and EU that preparations should be stepped up for a no-deal scenario. UK Prime Minister Theresa May has said she will take the lead on talks with the EU, a move seen by some as undermining the position of newly-appointed Secretary of State for Exiting the EU Dominic Raab, who was named to the post following the resignation of David Davis.

In the meantime, the EMA has also published two updated documents on the UK withdrawal from the EU, including an updated Questions & Answers document (and a new version of its practical guidance for procedures related to Brexit.

MHRA moves to Canary Wharf

On 18 June, the UK Medicines and Healthcare products Regulatory Agency (MHRA) moved out of its former location in Victoria to a new office in Canary Wharf. The relocation follows the establishment in 2016, announced by the Cabinet Office, of a new government hub for more than 5,000 civil and public servants in East London. The centres moving include: the MHRA regulatory centre, including the British Pharmacopoeia (BP), and the Clinical Practice Research Datalink (CPRD).





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