In this week’s news, EMA advice on shortage prevention, FDA review drugs on time says GAO and more…
EMA says change management process can prevent shortages
The EMA says drug firms can use its exceptional change management process (ECMP) to prevent drug shortages during the Covid-19 pandemic.
The Amsterdam-based regulator made the comments in a Q&A document that made clear what it expects in areas like authorizations, manufacturing and imports, quality, product information and labelling.
It wrote “an exceptional change management process (ECMP) can help MAHs source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorization if that is necessary to prevent/mitigate shortages of supplies in the EU.”
The process allows drug firms to source from CDMOs and services companies not listed in the initial approval documents.
Compassionate use requests
Developers can ask EU member states to green light unapproved drugs for “compassionate use” during pandemic says the EMA.
The EMA said, “In cases where no centralised/relevant national marketing authorisation exists, Member States can make use of possibilities foreseen in Directive 2001/83/EC, including resorting to compassionate use, or authorisation of the distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.
“To permit prompt assessment of these requests, applicants are requested to identify any such communication to the relevant NCA with the message “CONCERNS COVID-19”.
US FDA and EMA advise on use of plasma to treat Covid-19
US FDA and EC have issued guidelines on the therapeutic use of plasma from recovered Covid-19 patients.
The documents (here and here) provide recommendations to health care providers and investigators on the administration and assessment of blood plasma in the treatment of SARS-CoV2 infection.
The FDA acknowledged the potential of plasma therapy – citing its use in the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic and the 2012 MERS-CoV epidemic – but advised caution.
It wrote “Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19.”
The EC also discusses the safe use of plasma therapies. In addition it covers issues like plasma collection, testing, processing, storage and distribution. It also explains plasma testing and how researchers can submit clinical outcome data.
EMA sets up Covid-19 task force
The EMA has set up a task force to coordinate development and oversight of drugs and vaccines for coronavirus disease.
The regulator announced the task force this week. It said the task force, called COVID-ETF, will review scientific data for products in development. It has also been tasked with to collecting data from developers to identify promising candidates against the virus.
The task force will provide scientific support for trials in the EU and feedback on medicinal product development to sponsors.
US FDA drug reviews on target says GAO
The US FDA is meeting its drug review goals according to a review by the US Government Accountability office.
The GAO published the review last month, explaining it assessed 637 new drug applications submitted to the regulatory between 2014 and 2018.
The reviews wrote “Before a drug can be marketed in the United States, the FDA must determine it is safe and effective.
“The company or entity seeking to market the drug must submit evidence for review. FDA’s goal is to complete 90% of these reviews within deadlines that vary depending on the drug.”
Also in the news
FDA Commissioner Stephen Hahn says China is not blocking drug or API shipments according to Bloomberg. The comments follow allegations the Chinese Government had imposed export restrictions on key medicines and actives.
Chinese developer CanSino says it plans to move its coronavirus vaccine candidate into Phase II clinical trials in the near future, based on positive results in a Phase I study.
Some developments of note in the contracting space:
Cambrex has completed the expansion of its manufacturing facility in Durham, North Carolina. See press release.