In this week’s news, US FDA talks track and trace, EMA updates on ‘Dam plan, EC blames “anti-vaxers” for measles surge and more…
US FDA talks tagging in latest track & trace discussion
The US FDA has hosted a third discussion about track and trace requirements due to be introduced under the Drug Supply Chain Security Act (DSCSA).
The regulator held the meeting last week, inviting interested parties to discuss package level electronic tagging rules that will be implemented in November 2023.
According to the agency, “Stakeholders have asked FDA to provide “guardrails” to assist with the development of an electronic, interoperable system.”
The Drug Supply Chain Security Act outlines track and trace requirements for manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers.
Implementation of the act started in 2014, with several key requirements being introduced in 2015 and in subsequent years.
Tracking data dos and don’ts
In related news, the FDA has published draft guidance outlining how manufacturers and suppliers should standardise product tracking data.
The document discusses how the information should be prepared and shared electronically.
US will accept plant audits by Czech Republic, Greece, Hungary, and Romania
The US FDA has said it will accept the results of facility inspections conducted by regulators from the Czech Republic, Greece, Hungary and Romania under its mutual recognition deal with the EMA.
There are now 12 European Union Member States whose inspection results the FDA will accept when the agreement becomes operational in 2019.
The EMA and FDA have been trying to find a way to work together on drug production facility inspections since 2014.
Last year the agencies agreed to recognise each other’s inspections explaining the agreement will let them make best use of “resources to help them to focus on other parts of the world where APIs and medicines for the EU or US markets are manufactured”.
EMA board backs plans for new Amsterdam HQ
The European Medicines Agency’s (EMA) Management Board has voted to approve Dutch plans for its new HQ in Amsterdam.
The board, which met in Lisbon, Portugal last week, confirmed that Dutch authorities have committed to building brand new, tailor-made permanent premises. The site is due to be operational in November 2019.
EC slams anti-vaxers and fake news as measles rate soar
The European Commission has raised concerns about the “anti-vax” lobby, citing the increased incidence of preventable diseases in Europe.
EU Commissioner for health and food safety, Vytenis Andriukaitis, said, “Increasing vaccine hesitancy and the activities of so-called “anti-vaxers” is leading to … a potential public health scandal.”
There were 14,451 cases of measles in Europe last year according to the ECDC, which is a three-fold increase on 2016.
Andriukaitis blamed “antivaxers” and fake news, which he said had eroded public trust in vaccines.
EU chemicals output report
European chemical production increased 3.6% last year according to data published by the European Chemical Industry Council (Cefic).
The trade association announced its industry snapshot last week explaining that production of specialty chemicals – including those used in pharmaceutical manufacturing – and consumer chemicals was far above the level achieved before the economic crisis of 2008.
Also in the news
US politicians met to discuss ways of curbing the opioid crisis. Read the House Energy and Commerce committee report here.
Pharma-IQ has published a list of what it claims are the world’s 10 best CMOs.
Switzerland has reported a surge in fake drug shipments.
A judge has set March 9 as the sentencing date for Martin Shkreli, aka “pharma bro.” Find out more.
The snowstorm that hit Ireland last week halted production at several sites. See the full report here.