In this week’s news, US FDA chief steps down, EU revamps side-effect reporting system, TGA updates GMP guidelines and more…
US FDA publishes device facility inspection guidelines
The US FDA has issued draft guidance on medical device facility inspections.
The guidelines – available here – set out how FDA staff will conduct inspections. The agency said they will help manufacturers prepare and “set baseline communication and timing expectations.”
Specific topics covered include information on the records inspectors will want to see. The document also makes clear that inspections can last from three to six days.
The number of device facility inspections carried out by the FDA has increased in the past decade. The agency said the draft guidelines would help it make better use of resources.
Gottlieb welcomes FDA funding increases
Outgoing FDA commissioner Scott Gottlieb has welcomed the US Government’s decision to increase his agency’s budget.
Gottlieb, who stepped down in April, made the comments during his final address to the US Senate Subcommittee on Appropriations. He welcomed the increase and urged members to consider a similar move next year.
He said, “The new funding will help the agency modernize our approach to medical product manufacturing and ensure the quality of compounded drugs. You’ve provided key support for us to advance competition through generic drugs, and to use real world evidence to improve our understanding of the benefits and risks of drugs and devices, across the product lifecycle.”
Gottlieb also called for more funding for efforts to combat the opioid abuse epidemic, which has seen thousands of US citizens die from overdoses in recent years.
EMA revamps side effect reporting system
The European Medicines Agency (EMA) has updated its side effect reporting tool to make it easier for regulators, manufacturers and patients to flag problems.
The Amsterdam-based agency announced the new version of the EurdaVigilance System last week, explaining it is for approved drugs and those in clinical trials.
The EMA saw a 37% increase in adverse event reports last year after it asked national regulators and drug firms to record non-serious cases of suspected adverse reactions. Previously, only serious cases were reported.
The number of patient reported events also increased in 2018. The EMA said, “Improvements in patient reporting also reflect efforts at national level to encourage patients to share information on side effects through information campaigns.”
TGA updated GMP guidelines for firms seeking facility approval
The Australian Therapeutic Goods Administration (TGA) has revised guidance for firms seeking GMP clearance for an overseas drug or API plants
The revision covers instances when applicants have not paid fees. In such circumstances, the TGA will halt all review activities related to that application until payment is made.
EMA issues Brexit Q&A; MHRA provides ‘no-deal’ guidance
The EMA issued a Q&A document outlining how to prevent drug shortages after Brexit.
According to the agency, if the UK leaves the EU under the withdrawal agreement, drug supply chains will be maintained during the transition period. But, if the UK withdraws it warned some companies may have to make regulatory changes to follow EU law. Read more here.
Also last week, the UK MHRA published guidelines on conditional marketing authorisation. The CMA programme is for diseases for which no treatments are available.
It said, “Applicants wishing to submit an application for a conditional marketing authorisation to the MHRA should state their justification for a CMA and indicate clearly what clinical studies are underway and when comprehensive clinical data will become available.”
Also in the news
The Pinksheet looked at the pros and cons of outsourcing gene therapy manufacturing to a CDMO.
ANDA suitability petitions were covered in a feature article on the FDAlawblog site.
Lachman Consultants looked at how demand from the dietary supplements sector is impacting contractors working in the pharmaceutical space.
The EMA approved a gene therapy called Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) for transfusion-dependent β-thalassemia (TDT). The product, which was developed by Bluebird Bio, was reviewed via the EMA’s accelerated approval pathway.
Indian drug and API manufacturers are still struggling to access the Chinese drug market according to a report by Pharmabiz.
Thermo Fisher is to buy Brammer Bio for $1.7bn according to a report in the Wall Street Journal.