MHRA says it will review plans for new UK pharma plants free of charge
When AstraZeneca choose a Macclesfield site for its Zoladex delivery device manufacturing plant last November, the news was greeted as an indication the drugmaker intended to keep a presence in the UK despite previous cutbacks at sites in Alderly Park and Brixham.
UK chancellor George Osborne called the investment “great news for the community” describing it as something he and Macclesfield MP David Rutley had “fought really hard along with the local council and local people to achieve.”
Another factor that prompted AstraZeneca to build in the UK was advice provided by the MHRA according to Gerald Heddell, director of inspection, enforcement and standards, who told in-Pharmatechnologist.com the decision to seek regulatory help early, speeded up the planning process.
“Both plants constructed with less MHRA collaboration and those with full involvement, must ultimately meet the necessary standards but in the case of AstraZeneca the early intervention allowed them to meet their targets more quickly.”
Heddell explained that AstraZeneca approached the MHRA for a review of the construction plan that involved site visits, manufacturing technology assessments and detailed analysis of its validation strategy.
He also said that: “The Government encourages us as a general rule to support innovation in medicine. However AstraZeneca came to us independently of any government advice.”
The approach differs from when fellow UK Big Pharma firm GSK decided to invest £370m in a manufacturing plant in Ulverston, Cumbria. The UK firm only confirmed the investment after the Government introduced tax cuts the firm had lobbied for for several years.
GSK's investment decision also followed CEO Andrew Witty’s receipt of a Knighthood in the 2012 honours list.
All pharmas big and small
While large investments like the AstraZeneca project may attract attention, the MHRA is keen to work all types of companies on innovative manufacturing facilities according to Heddell.
“The size of the company makes no difference to us. Some of the new enquiries, whose case studies will be published next year, are from small companies” he said, adding that: “We have not charged for this guidance. We do not charge for early innovation.”
He stressed that the MHRA’s willingness to help on facility development does not guarantee the firm involved that any drugs produced there will be approved.