In this week’s news, EMA voices more Brexit concerns, ABPI flags key points in UK Gov whitepaper, US FDA chief calls for investment in innovative drug manufacturing and more…
EMA worried about Brexit impact on UK-made, centrally authorized drugs
Nearly 100 UK-made drugs could lose approval after Brexit according to the EMA, which says some manufacturers may not have enough time to comply with the new regulatory landscape.
The Amsterdam-bound Agency issued the warning after conducting a survey of 694 centrally authorised products that have “an important step in their regulatory processes in the UK.”
The EMA said while most manufacturers are on track to make the changes needed to ensure their authorisations are valid after the UK leaves the EU, a sizable minority are not.
“For 108 [CAPs] (88 human products and 20 veterinary products), or 16%, of these medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.
The Agency did not name the drugs at risk of losing validation, but did urge their manufacturers to take action.
A marketing authorization for a CAP requires the holder, the qualified person for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF) and certain manufacturing sites to be based in an EEA country.
ABPI highlights five key points from the UK Government Brexit plan
The ABPI says Government proposals for the UK’s post-Brexit relationship with the EU clarify several issues for the drug industry.
The UK Government issued its plan in a whitepaper last week, setting out how it envisions future trading and regulatory interactions with EU.
Some details are still to be thrashed out – not least whether the EU will accept any of the proposals. However, according to the ABPI, the paper does at least clarify the Government’s position on some pharma-relevant topics.
For example, the group highlighted the fact the proposal for “frictionless trade through a common rule book and customs agreement” includes adherence to EU GLP and GMP requirements.
The ABPI also noted the request to let drug firms use UK-based QPs for batch release pointing out that, under current EU rules, release must be carried out in a member state or EEA country.
According to the ABPI, the Government also wants the UK to keep its EMA membership – albeit without voting rights -, retain access to EMA IT and data, and maintain involvement in the EU surveillance lab network and ECDC.
Likewise, the ABPI says the Government has asked that UK researchers be allowed to take part in future EU funded research programmes.
US FDA says 3D printing and continuous manufacturing can boost US pharma
US FDA commissioner Scott Gottlieb has reiterated support for innovative drug making technologies and said investment is still needed.
In a blog last week, Gottlieb wrote that new tech “can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the US.”
He cited 3D printing and continuous manufacturing as examples of innovative approaches starting to be applied to drug manufacturing, but added that more investment is needed from industry and regulators.
“Harnessing the potential of these innovations requires deliberate private and public investments and new policy development,” Gottlieb said, adding “We need to define how these new technologies will be regulated for their reliability and safety.
Also in the news
The UK Government is offering a £10m research grant to scientists who can develop new ways of tacking antimicrobial resistance (AMR). Read the full report at Pharmaphorum.
UK drug prices may be higher under proposed US trade deal according to Bloomberg.