In this week’s news, EMA revises Brexit Q&A, EFPIA members to disclose doctor payments, US FDA updates fee waiver info, and more…
EMA updates Brexit prep guidelines for pharma
The EMA has updated its Brexit guidance for drug manufacturers.
The revised document is intended to help both UK-based pharmaceutical companies and those serving the market to prepare for Britain’s withdrawal from the European Union next March.
It provides information on how the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR) will be impacted.
It also clarifies how scientific opinions for ancillary medicinal substances in medical devices that have been requested by UK notified bodies will be affected.
The EMA has also included information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPVs) and on marketing multi-country packs of medicines, where packs will be sold includes the UK.
European pharma to share details of relationships with doctors and patient groups
Drug manufacturers in Europe will share details of their interactions with doctors and patient groups by June 30 according to EFPIA.
The Industry group shared details in a post last week, explaining that the information will be available online.
It said the move underlines “industry’s continued investment in European healthcare, enabling the development of new medicines through sharing best clinical practice, exchanging information on how new medicines fit into the patient pathway and shaping the future of clinical research.”
Specific information will include details of research and educational grants to healthcare organisations as well as transfers of value to individuals for activities such as speaking at educational meetings.
US FDA updates fee information
The US FDA has issued revised guidelines for drug companies thinking of asking for a fee reduction.
The document – available here – updates on previous guidelines that were issued in 2011. It includes details on the type of waivers available, and how reductions and refunds are calculated.
It also makes clear that waivers are offered to industry if there is pressing public health needs and when the fee would be a significant barrier to an applicant’s ability to develop a drug.
Also in the news
Recipharm has acquired a UK manufacturing facility from French drug firm Sanofi. Read more at in-Pharma.
EMA chief Guido Rasi tells Amsterdam in Business magazine about the agency’s move to the Dutch capital.
Reuters reports that US tax reforms may benefit drug companies that move profits to off shore havens.