A major cooperation milestone has been reached between the European Commission & the US FDA.
November 2017 sees a mutual recognition agreement drafted, enabling the recognition of inspections of manufacturing sites for human medicines conducted in their respective territories. This cooperation will aim to improve the use of available resources to safeguard quality and safety of medicines.
The agreement enables both the EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.
European Medicines Agency
The FDA has released draft guidance for its new Breakthrough Medical Device Programme which will replace the current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.
Features included in the new guidance:
- Review of product which could lead to jumping the queue
- More interactive communications
- Post Market data collection in lieu of Pre Market data collection
- Ease sponsors’ clinical study design obligations
- Support from FDA review teams
- Expedited review of manufacturing sites
- Impacts 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.
For more information or a discussion with our experts on how this impacts your medical device products please reach out to Instem and the Samarind RMS team on [email protected] or call the team on +44 1244 287 900.
The Instem team are off once again and are attending this years CPhI. A great show and another opportunity for you to meet with us face to face!
Are you going to the show? Want to set up a meeting with our experts attending the show?
Contact us on [email protected] or call a member of the team on +44 (0) 1244 287 900 to secure your time slot.
Instem is proud to once again to sponsor the TOPRA awards for regulatory excellence! Our product Samarind RMS supports the award for Innovation and will be represented by our team and customers at this years awards dinner. This year’s venue will be in London at the historical Waldorf hotel!
We wish all nominees the best of luck and look forward to cheering you on in November.
Join our team at this years TOPRA Symposium!
Each year Instem attends this great event to showcase its fantastic solution Samarind RMS. Swing by our booth to discuss how we can help you with the changing global regulations and ensure you are prepared for IDMP, FDA UDI, EU MDR, and beyond.
If you would like some one-on-one time with our booth staff book a slot using the email address [email protected] or call the team on +44 1244 287 900.
The FDA are currently setting up a pilot programme on several high risk medical devices, they hope that the outcome of this programme will allow them to have a more efficient PMA process.
Currently the authority is searching for nine applicants who will be enrolled from the end of September 2017 to Dec 2018, as soon as nine suitable applications are accepted the pilot will begin. It has been noted that the FDA are focusing on the quality issues of the pre-market process in order to drive down high-risk device recalls, with the ultimate goal to streamline the complex and expensive PMA process without compromising controls for safety and effectiveness of devices.
This initiative could lead to less costly and time-consuming PMA requirements for manufacturers of high-risk devices.
Here at Instem we understand that the PMA process can be long, costly and error prone. We hope that this pilot is successful and our customers can get their products to market more efficiently.
If you wanted to speak to any of our experts about Medical Device submissions or to view our solutions that will help bring your life enhancing products to market faster please reach out to us.
Speak to our team via email [email protected] or call us on +44 1244 287 900.