In this week’s news, US rejigs rules on biologics inspections, EC calls for feedback on EMA fees, FDA-EMA collaboration cuts inspections and more…
US FDA eases biologic drug firm’s inspection burden
Biologic drug firms supplying the US market no longer have to undergo biennial facility inspections after the FDA revised its audit rules last week.
The US regulator announced the rule change in the Federal Register last week, explaining it had “received significant adverse comment” about the regulation from industry.
Previously, all facilities making biologic drugs for the US market had to be inspected every other year.
However, as the FDA pointed out in January, arbitrary audits are ‘outdated’ and not in keeping with risk-based protocols called for under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).
European commission calls for feedback of EMA fees
The European Commission has asked drug manufacturers whether fees charged by the EMA are fair and justified.
The Commission launched the public consultation last Wednesday.
According to the survey the aim is to find out if the current fee system is “cost-based, fair, proportionate and not unduly complex.”
At present, the EMA gets its money from contributions from EU and EEA member states and fees paid by companies seeking approval for drugs, medical devices and other products.
Currently, it costs €286,900 to submit a marketing authorization application for a drug. The EMA also charges for scientific advice, charging from €43,000 for guidance on applications.
EMA reports fewer facility inspections conducted in 2017
EMA inspectors audited fewer pharmaceutical manufacturing plants last year as a result of the agency’s deal with the US FDA.
According to the EMA’s annual report published last week 397 GMP plant inspections were conducted by EU member state regulators in 2017, down from 673 audits carried out in 2016.
The agency said the reduction in inspections was a result of the mutual recognition deal it signed with the US FDA, under which the agencies agreed to recognize each other’s audit reports.
The EMA also said fewer problems were identified at the facilities that were inspected.
Also in the news
A gene therapy advocate discusses pricing in an article in STAT. She questions how industry can make drugs like Spark Therapeutics’ $425,000-a-vial vision loss therapy Luxturna more accessible.
PWC published a report on global healthcare that focuses on how M&A, partnering and disruptive business practices are reshaping the sector.
The European Commission has called for expressions of interest from NGO representatives interested in joining the EMA’s management board.
Scroll.in reports that international pharmaceutical firms and the US Government are calling for India’s patent laws to be reformed.