In this week’s news, EMA rejigs environmental testing rules, FDA headed for Amsterdam, plan to boost HIV drug access and more…
EMA rejigs environmental testing reqs for drugs
The EMA has changed how firms should test drugs’ environmental impact with a focus on those likely to interact with hormones, so called ‘endocrine disruptors.”
The currently London-based regulator published the revised guidelines last week, introducing a decision tree that clarifies how and why manufacturers must carry out environmental risk assessments (ERAs).
The Agency wrote, “The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these substances have shown direct effects on wildlife at or below the concentrations found in water and soil.
“For example, male fish exposed to the main ingredient in the contraceptive pill may become feminised and this can affect the capacity of the population to reproduce.”
The document also addresses “secondary poisoning” in predators exposed to pharmaceuticals in the environment that pass through the food chain.
The EMA says the revision proposes to limit use of a laboratory test method – the Organisation for Economic Co-operation and Development (OECD) 308 environmental fate test – to certain categories of substances.
US FDA to follow EMA to Amsterdam
The US FDA has confirmed it will follow the EMA’s lead and set up an operation in Amsterdam.
The US regulator announced its plan last week as part of a discussion of its global effort to protect patients and consumers from unsafe products.
Mark Abdoo, Acting Deputy Commissioner for Global Regulatory Ops, said since opening its first overseas office in Beijing in 2008, the agency has set up operations in New Delhi, Brussels and London as well as cities in Latin America.
“By maintaining an office in both Brussels and London (eventually Amsterdam), we can better leverage our resources and collaborate with our regulatory partners on higher-risk sites around the globe that sell food and medical products to both Europe and the United States.”
The EMA is due to relocate from London by the end of March next year as a result of the UK’s current plan to withdraw from the European Union.
US FDA aims to boost access to HV drugs
In other news, the US FDA has said it plans to work with the WHO and drug manufacturers to increase access to HIV medications.
The regulator said it will aim to expedite the assessment of antivirals, particularly in countries where access to medicines is limited.
Anna Abram, the FDA’s deputy commissioner for policy, planning, legislation and analysis wrote, “Today we are announcing a pilot program with the World Health Organization (WHO) designed to expedite the review of HIV drug applications submitted to WHO’s Prequalification of Medicines Programme (PQP).
The aim is to “minimize duplication of efforts by the FDA and the WHO and help regulatory authorities in nations with limited resources make decisions faster.”
The pilot scheme – the Collaborative Registration Procedure-Lite (CRP-Lite) – will see the FDA pass redacted information to the WHO – with the applicants’ permission – to accelerate the Geneva-based organisation’s assessments.
European Council agrees next Horizon Europe regulatory plan to 2027
The European Council has agreed the outline for the cross national research scheme Horizon Europe through to 2027.
The plan sets out regulatory priorities for scientific research and includes a numbers of areas that are of relevance to the pharmaceutical development and manufacturing industry.
According to industry group EFPIA backed the agreement, writing, “European Research Framework Programmes have a proven track record of directly supporting medical and health system innovation, patient access to innovative healthcare solutions, Europe’s cohesion and growth, as well as the continuing attractiveness of Europe as a location for life sciences and investment.”
Also in the news
FDAzilla looked at how pharmaceutical companies should go about assessing the contract research organisations (CROs) with which they work. Read more here.
Germany’s Boehringer Ingelheim changes biosimilars plan. Find out more at Bioprocess Insider.
Medpagetoday looked at the cost implications of treating asthma with biopharmaceuticals.
STAT covered ongoing questions about the use of gene editing in humans.
The WHO has published a list of diseases for which new antibiotics are desperately needed.