In this week’s news, US FDA shares overseas inspection methods, EMA clarifies MHRA role and more…
US FDA publishes overseas plant inspection policy
The US FDA has shared details of its approach to inspecting overseas API and drug manufacturing facilities for the first time.
FDA commissioner Scott Gottlieb announced the publication last week, explaining the idea is to make clear how the agency decides which plants to visit and how it goes about assessing the quality of operations.
He said, “Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.”
According to FDA data, inspectors visited 5,063 manufacturing sites in 2017, some 3,025 of which were outside the US.
The agency also revealed it has carried out 1,453 drug surveillance inspections – which look at how well a manufacturer is adhering to GMP – in 2017, 762 of which were overseas.
Gottlieb stressed the importance of inspections in ensuring drug quality, adding “To accomplish this critical work, we need to maximize our resources around the globe, which is why the FDA uses a risk-based site selection model to ensure that inspectional resources are allocated in the most efficient and appropriate manner to protect patient health.”
In addition to risk-based inspections, the FDA has also teamed up with regulators in other regions to share inspection resources more effectively. The agency predicted that the benefits of the mutual recognition agreement would be reflected in the 2018 inspection figures.
EMA clarifies MHRA’s ongoing role during countdown to Brexit
Reports the MHRA has lost drug review and assessment ‘contracts’ with the EMA are inaccurate according to the agency.
Last week a Guardian report stating that “Britain loses medicines contracts as EU body anticipates Brexit” said that the MHRA is no longer being asked to evaluate drugs on the EMA’s behalf in preparation for Brexit.
When asked an EMA spokeswoman told us “The Guardian article refers to the work carried out on behalf of the EU regulatory network by the UK’s competent authority, the MHRA, i.e. rapporteurships and co-rapporteurships; we do not award ‘contracts’ as mentioned in this article.”
At present, employed authorities like the MHRA work with the EMA as members of scientific committees, working parties, advisory groups and other ad-hoc groups as well as members of the assessment teams carrying out the evaluation of medicines.
Contrary to the Guardian report, the EMA spokeswoman told us “The MHRA still participates in EMA activities and will continue to do so until the UK withdraws from the EU.
“However, in order to protect animal and public health we have to prepare for the scenario that as of 30 March 2019 the UK will be a third country and it may no longer participate in the work of the Agency.”
She explained that rapporteurs appointed to assess drugs must be ‘available’ for the duration of the review, adding that “As the average length of a centralised evaluation for initial marketing authorisation applications is more than one year, UK representatives can no longer be considered for appointment as rapporteurs or co-rapporteurs.
The spokeswoman confirmed that, in April, the EMA redistributed the UK’s portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway, in preparation for Brexit.
Pfizer says Brexit will cost $100m
In other Brexit news, US drug manufacturer Pfizer has predicted that the UK’s withdrawal from the EU will cost it $100m in lost revenue and higher expenses.
According to Pharmafile, Pfizer has said costs associated with the transference of product and testing licenses to other countries, changing clinical trial management procedures and other preventative measures will amount to $100m.
Pfizer told the publication it “is working to meet EU legal requirements after the UK is no longer a member state, especially in the regulatory, manufacturing and supply-chain areas”.
Also in the news
Novartis will sell drugs from its Sandoz US dermatology business and generic oral solids portfolio to Aurobindo Pharma USA. Read the full report at WorldPharmaNews.
Indian drug firm Lupin says it will train 1,000 under graduates in pharmaceutical manufacturing by 2020 according to a report in the Economic Times.
Pharmaceutical Technology reports that a former GSK employee named Yu Xue has plead guilty to trying to steal trade secrets for biopharmaceutical products in development to treat cancer and other diseases.
GEN looked at how the biopharmaceutical industry is adopting continuous manufacturing.