BLOG & news
FDA updates Q&A Guidance on Inspections and Applications
How will limited inspection activities affect applications?
FDA states that it is “using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA’s ability to inspect due to COVID-19.” Examples:
- FDA will continue the quality assessment of all applications per normal assessment operations (using a risk-based approach).
- Additional tools will be used wherever possible (review of the compliance history, using shared information from other foreign agencies, requesting records “in advance of or in lieu of” facility inspections).
- FDA will continue to work directly with the applicants and encourages those “to be in communication with all their facilities and sites to ensure timely responses to any inquiries“.
Further information can be found on the here
EMA: Medical Device Regulation comes into application
Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.
The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period.
Further information can be found on the here
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
On Monday 24 May 2021, the TGA approved an application from Pfizer Australia Pty Ltd to change its current storage conditions for its COVID-19 vaccine, COMIRNATYTM. The TGA received the application on Thursday May 20, 2021.
This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal refrigerator after taking out of deep-freeze conditions) at the point of use from five days up to one month (31 days). The changed storage requirements will enable much greater flexibility in the distribution of the vaccine and have a significant impact on the roll out of the vaccine across Australia.
The TGA made this decision based on review of additional stability study data submitted by Pfizer – and follows recent similar approvals in some other countries. Changes to storage conditions are included in the Product Information(link is external) for COMIRNATY, users are reminded to refer to this document for correct and up to date information.
Further information on the COVID-19 vaccines can be found on the here
Medsafe takes action to prevent supply of illegally marketed medicine linked to liver harm
Medsafe has withdrawn its prosecution of Promisia Integrative Ltd in relation to its product Arthrem, in return for an agreement that will see the product removed from supply.
The settlement means Promisia accepts it breached the Medicines Act and will now cease manufacturing, advertising and selling Arthrem which has been linked to serious cases of liver harm.
In turn, Medsafe has agreed to withdraw the nine charges laid in the District Court against the company last year.
The prosecution of Promisia Integrative Limited, began in January 2019, followed Medsafe’s earlier warnings to the company about the sale, supply and advertising of Arthrem.
The company was warned that its advertising of Arthrem breached the Medicines Act.
Promotional claims made by the Company about Arthrem’s use for arthritis effectively made the product a medicine, which was unapproved, and was in breach of the Act.
Learn more about the changes and what you’ll need to do here LINK
EMA: New treatment for rare autoimmune disease of nerve cells
EMA has recommended granting a marketing authorisation in the European Union (EU) for Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adults and adolescents from 12 years of age who are positive for anti-aquaporin-4 antibodies (AQP4-IgG).
NMOSD is a rare and life-threatening condition and most commonly affects the optic nerves and spinal cord. This disorder can lead to reduction or loss of vision, loss of sensation, loss of bowel and bladder control, weakness and paralysis of the arms and legs. NMOSD is thought to be caused by an abnormal reaction of the immune system that causes damage to healthy nerve cells. It is characterised by relapsing attacks, with symptoms coming back periodically. It is estimated that NMOSD affects approximately 1-2 in 100,000 people in the EU.
Learn more about the changes and what you’ll need to do here LINK
Nicotine e-cigarettes laws are changing in Australia
If you currently use nicotine e-cigarettes, you need to be aware that from 1 October 2021 you will no longer be able to legally buy these products from overseas websites without first talking with a GP and getting a prescription. The main reason a GP may provide a prescription is for the purposes of smoking cessation.
If you currently use nicotine e-cigarettes, you need to be aware that from 1 October 2021 you will no longer be able to legally buy these products from overseas websites without first talking with a GP and getting a prescription. The main reason a GP may provide a prescription is for the purposes of smoking cessation. Learn more about the changes and what you’ll need to do here LINK
