In this week’s news, EMA talks kids’ med trials, US FDA mulls heartburn drugs, device sector set for quality shake up and more…
EMA wants feedback on draft paediatric trial prep framework
The EMA has asked for industry feedback on a plan to help developers study candidate medicines in children.
The Agency issued the consultation document last week, explaining it is designed to provide a way of assessing how prepared the company is to conduct a paediatric study.
It said the aim is to “increase the likelihood of a smooth and timely course of a paediatric clinical trial.”
Drug firms developing products for children are required to study them in children under a Regulation passed in 2007.
In the new document the EMA acknowledged that trials in kids can be more complex that studies in adults, particularly in relation to consent and ethics.
It wrote, “Paediatric drug development plans and studies can be difficult to carry out…The extent of these difficulties varies between studies.
“According to the results of our survey sites often over-estimate what is possible and it was reported that sponsors, regulators and ethics committees can disagree about what should be done or is possible during drug development.”
US FDA and EMA scrutinise heartburn meds over impurity concerns
Regulators on both sides of the Atlantic have started testing heartburn drugs over concerns about potential contamination.
The FDA wrote it “has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called NDMA at low levels.”
The new investigation was prompted by an earlier review of blood pressure medicines – specifically those containing the API valsartan made by Chinese supplier Zhejiang Huahai – that were found to contain NDMA.
The review concluded that the risk is minimal. According to the EMA “if 100,000 patients took the blood pressure medicine valsartan every day for six years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients.”
Device sector needs to prepare for changes to quality regs says group
The Association for the Advancement of Medical Instrumentation (AAMI) has released a report to help device firms prepare for changes to US quality regulations.
The AAMI published the document last week, explaining the aim is to help developers get ready for changes to 21 CFR 820, which is due to be aligned with ISO 13485:2016 later this year.
The organisation wrote, “This document provides a mapping of the US FDA 21 CFR requirements to the “regulatory requirements” references in ISO 13485:2016.
“This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.
The US FDA has said it will make a proposal on modernisation of device quality regulations based on specifications outlined in the ISO document this month.
Also in the news
Pharmalot reports the US FDA has increased the number of drug plants it inspects overseas while reducing the number of domestic facilities it audits.
US industry group BIO had defended the pharmaceutical industry against accusations it hikes the price of products. See full STAT report.
Many generics are failing to take market share from branded products according to analysis by Lachman Consultants.
Some developments of note in the contracting sector:
Avid Biosciences is planning a major investment in its manufacturing network. The CDMO told Bioprocess Insider the recent addition of new customers was the main driver for the expansion. See full story here.
Acura Pharma has hired Catalent to develop LTX-03, a candidate pain drug. The contractor will use an anti-abuse tech that prevents active ingredient release when too many tablets are ingested. See press release.
Covance has opened a new R&D centre in Shanghai, China. See the full press statement.
Mallinckrodt has announced plans to sell its contract manufacturing business. See the full story at Fiercepharma.