In this week’s pharma news, Guido Rasi talks staff retention, EMA and FDA expand collaboration, Ireland to join BeNeLuxA initiative and more…
EMA will retain fewer staff than expected post Brexit
The European Medicines Agency (EMA) will retain fewer staff than originally predicted when it relocates to Amsterdam next year.
Executive Director Guido Rasi told Bloomberg the agency could lose 19% of its 900 staff when it relocates from London after the UK withdraws from the European Union (EU) next March.
Previously the agency predicted that moving to the Dutch capital would allow it to keep 81% of its staff.
According to Pharmaphorum, Rasi does not expect drug approvals to be delayed as a result of the additional staff losses. He also confirmed the EMA has a reserve list of 1,000 applicants keen to work for the agency.
The news comes a week after construction of the EMA’s headquarters began in Amsterdam’s Zuidas region. Until the building is operational, the agency will be based at a rented office in the city’s Sloterdijk district.
EU-US Mutual recognition expansion
In related news, the EMA and the US FDA have agreed to recognise facility inspection data from audits conducted by regulators in Lithuania and Ireland.
The EMA said, “The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.”
“Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.”
According to the European Commission, the original rationale for the agreement was to reduce the inspection burden on both regulators and manufacturers and streamline the oversight process.
Ireland is poised to join BeNeLuxA Initiative, a drug pricing, reimbursement and access collaboration established by Belgium, the Netherlands, Luxembourg and Austria according to reports last week.
Ireland expressed an interest in joining the group in February.
At the time Minister for Health, Simon Harris said, “The BeNeLuxA collaboration… will allow Ireland to explore opportunities, in an increasingly challenging environment of high pricing of medicines by pharmaceutical companies, to secure sustainable and affordable access for patients to new and innovative medicines.”
IGBA elected to ICH management committee
The ICH General Assembly has elected the International Generic and Biosimilar Medicines Association (IGBA) as a Management Committee Member.
The IGBA, which represents regional generic drug industry groups, joined the ICH as an assembly member in 2016. Membership of the ICH’s management board means it will play a greater role in standards development.
The IGBA said, “Deeper integration and involvement of the IGBA in the ICH Management body will clearly contribute to development and promotion of the ICH regulatory standards among the IGBA membership in the benefit of patients’ worldwide, having an access to high quality, safe and efficacious generic and biosimilar medicines.”
Also in the news
Life science start-up Microbiotica has teamed up with Swiss drug firm Roche.
The deal positions the microbiome-based therapeutics firm to play a key role in the development of biomarkers and treatments for inflammatory bowel disease in partnership with Genentech. Read more here.
The UK Government is preparing for drug shortages after Brexit. Get the full story here.