In this week’s news, the EU gives the EMA more options to head off shortages, the US FDA offers generic drug firms and CDMOs pointers on review processes and more.
EMA gets more power to address drug shortages
The European Parliament cleared legislation that gives the EMA more power to track and respond to potential drug and device shortages.
The plan is for the EMA to set up two “steering groups” for drugs and devices that will try to head off potential shortages. The Amsterdam-based regulator will also establish a monitoring system and web page to provide information on supply disruptions.
Rapporteur Nicolás González Casares said: “The new regulation makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies.”
He added that the new laws provide “the Agency with a key tool to monitor medicines supply and prevent shortages. In short, more transparency, more participation, more coordination, more effective monitoring and more prevention.”
US FDA issues raft of new generics guidelines
The US FDA has moved to clarify the generic drug approval process with three new guidelines for CDMOs and pharmaceutical companies.
According to the US FDA, the documents – two final and one draft – are “part of our continued efforts to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices.”
The two final guidance documents – which cover abbreviated new drug applications (ANDAs) submissions and information requests and discipline letters respectively are designed to reduce “recurring deficiencies” that could delay the approval of a generic drug.
The draft guideline covers how generic drug product labels should be revised when the label for the reference product is changed.
Also in the news
California is a step closer to making biosimilar insulin according to Inside Health Policy, which reported that the high process charge for the drug prompted politicians to move forward with plans to sponsor local production.
The Wall Street Journal looked at GSK’s efforts to increase production of Sotrovimab, its antibody treatment for the omicron coronavirus variant. The plan will involve both Wuxi Biologics and Samsung Biologics, according to the article.
Reuters reported that advocacy groups want Pfizer to sell more of its COVID-19 treatment, Paxlovid, in developing countries to try and reduce the spread of the disease and generation of viral variants.
The COVID-19 pandemic has encouraged scientist to share data at an unprecedented level, according to a feature in Nature.
The Pink Sheet reported that the EU has extended provisions designed to ensure the continued flow of medicines now the Brexit transition period has ended.
SCRIP took a look at the rapid development of the gene therapy market in China, tracking the fast growth and high levels of investment in the sector.
Some developments of note in the contracting sector:
Austrian regulators have authorized Vetter to make medicines at its facility in Rankweil following an inspection. The site can support clinical development projects.
Treadwell Therapeutics has hired Genezen to accelerate production of T cell receptor (TCR)-based candidates to address unmet needs in cancer patients. See press release.
Element Materials Technology has completed the acquisition of JMI Laboratories (JMI), a provider of antimicrobial resistance monitoring study services for drug manufacturers.
Novasep will be part of the global supply chain for Pfizer’s novel protease inhibitor, PAXLOVID, which targets COVID-19. Novasep will make the drug API. See press release.
WuXi Biologics has completed a remote GMP inspection by South Korea’s Ministry of Food and Drug Safety for its drug substance facility (MFG2) in Wuxi city.
Colorcon Ventures has invested in Apprentice.io, a provider of Intelligent Manufacturing Execution Systems designed for the life sciences industry.
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