In this week’s news, EMA expects to lose more staff, China to crack down on vaccines sector, US FDA gives grants for continuous manufacturing research and more…
EMA outlines scale-back and warns of higher staff losses
The EMA has announced it will further reduce activities to prepare for Brexit and admitted it will retain fewer staff than expected after it leaves London.
The Amsterdam-bound regulator announced the measures last week, explaining that from October it will scale-back collaborations with agencies outside Europe, halt guideline development and instead focus on product-related requests and supply chain issues.
The EMA said, “The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated. Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to accelerate.”
The agency said it now expects to lose 30% of its workforce, adding that there is a “high degree of uncertainty regarding mid-term staff retention.”
The higher than expected staff loss is significant. In 2017, the EMA warned staff losses would hinder its ability to oversee the activities of pharmaceutical companies in the EU and likely delay approval decisions.
China to inspect all vaccine plants after testing data scandal
Chinese regulators have announced plans (here in Mandarin) to inspect all vaccine plants in the country after finding significant deviations at a facility owned by Changchun Changsheng.
Inspectors who visited the rabies and DPT vaccine facility in July found evidence the firm was using expired active ingredients and allegedly faking production data. A few weeks later, police arrested a number of executives at the firm according to FiercePharma.
In an announcement last week China’s recently formed State Administration for Market Regulation said it will inspect all manufacturing facilities involved in the production of prophylactic vaccines in the country.
The agency has not said how many audits are likely to be involved.
US FDA awards grants to ‘continuous manufacturing’ research projects
The US Food and Drug Administration (FDA) has followed up on its statements of support for ‘continuous manufacturing’ and awarded grants to groups developing such processes for drug production.
The US regulator announced the grants last week, explaining the 21st Century Cures Act empowers it to give funding to academic groups and non-profit organisations engaged in transformative research.
Rutgers University in New Jersey was awarded $2m for its work on continuous manufacturing and its implementation, MIT was given $3m for an analytics focused project and the Georgia Institute of Technology was granted just under a million for research focused on beta-lactam synthesis.
FDA Commissioner Scott Gottlieb said, “Continuous manufacturing utilizes technologies that offer clear benefits for both patients and industry. The approach has the potential to shorten production times and improve the efficiency of manufacturing processes. These benefits translate to lower cost of production and thus the cost of medicine.
US FDA to charge more for drug reviews
In other US FDA news, the agency has announced it will charge companies more to submit products for review from fiscal2019.
In a post in the US Federal Register, the agency said it will cost pharmaceutical developers more than $2.5m to submit a drug or biologic product for review, which is around $100,000 more than what it costs at present.
Also in the news
There were 33 major drug industry acquisitions in the first half of 2018 according to analysis by Pharma Intelligence, which reports that the average deal value was $4bn.