In this week’s news, regulators streamline for Covid-19 research, Australia starts virtual plant visits and more…
ICMRA collaborates on speeding Covid-19 trials
The International Coalition of Medicines Regulatory Authorities (ICMRA) is working to speed the development and approval of products used to fight coronavirus.
According to a statement this week ICMRA members – which include regulatory agencies from countries all over the world – are developing a consensus on data requirements for Phase 1 trials of COVID-19 vaccines, therapies for the disease and the use of real-world data and observational studies.
The organisation said, “ICMRA members stand ready and will continue to work together to ensure the regulatory processes related to COVID-19 are adequately efficient to help expedite the development and delivery of medical products of importance in the fight against COVID-19 to populations in need worldwide.
“We also won’t spare our efforts to mitigate drug shortages resulting from the global disruption caused by the pandemic.”
US FDA, EMA give advice to firms on trials during Covid-19
The US FDA and the EMA have issued update guidance on clinical trials during coronavirus pandemic.
The documents (here and here) aim to address problems associated with running clinical trials during the lockdown, covering issues such as communication, data management and informed consent.
According to the European Commission “The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety.”
Australian regulators start virtual GMP inspections
The Therapeutic Goods Administration (TGA) is carrying out virtual inspections of domestic manufacturers during the pandemic. The Australian regulator said virtual assessments will involve a desktop review of information to gauge the compliance of a manufacturing site with GMPs. The agency also said it will use a hybrid approach that combines a desktop review with “an on-site inspection under agreed, controlled conditions.
The TGA also plans to carry out full on-site inspections when safe to do so, or even defer audits under specific circumstances.
Cardboard shortage may impact drug packaging
Industry groups are warning that a shortage of cardboard may impact production of pharmaceutical packaging.
According to Packaging Europe the UK Recycling Association and Cepi, a European association representing the pulp and paper industry, waste paper collection must continue during the Covid-19 pandemic to maintain packaging supply chains. UK Recycling Association |CEO Simon Ellin said “Our members are hearing reports from all corners of the world that essential cardboard, paper, glass, metal cans, and plastics are in very strong demand. We’ve got to keep our supply chains open to ensure food and medical supplies can reach those who need it.
“If you think about medicine bottles or tubes, these are often protected by a cardboard box too. I know there is strong demand for essential recycled cardboard from manufacturers right now.”
Drug facilities in Baddi, Himachal Pradesh, India have shut down or cut capacity which is impacting global supply chains according to the Economic Times.
Bill Gates tells STAT innovation in drug manufacturing will be needed before the lockdown can end.
Merck KGaA has said it will spend $110 million to open a second viral vector facility in Carlsbad, California.
The US FDA and China’s NMPA have speeded up reviews and approvals of products that might be used to prevent or treat COVID-19. Read the full RAPS report here.
Some development of note in the contracting space:
Cytovance Biologics has entered into a collaboration with Akshaya Bio to provide rapid access to clinical materials using Akshaya’s proprietary Chimigen Platform Technology for vaccine development for COVID-19 and HBV.
Catalent has completed a $14 million expansion of its packaging facility in Indiana.
Johnson & Johnson has hired Emergent BioSolutions to manufacture its candidate Covid-19 vaccine and commercial supply if it is approved.