With the upcoming Sponsor Information Day being held in Canberra, there will be a great opportunity to network with others from the industry, and most importantly get face to face with our Regulatory Authority.
In the past, it was certainly the impression amongst the industry that our agency was not as transparent or as approachable as others within the world of Regulatory Agencies. Although this in some instances needs to be true, where the agency is responsible for the control of medical products being introduced and cannot be seen be bias, the TGA is certainly opening doors that industry have never been privy to before.
Most of this through recent times has been through consultation where Industry have the opportunity to reply directly to the agencies questions around various regulated areas. This has never been more so than following the Medicines and Medical Devices Review (MMDR). These recent consultations have included a range of pre-market questions and opportunities which included use of overseas regulatory authorities, designation of Australian conformity Assessment bodies, and also accelerated assessments of devices. All of these have a focus on pre-market. This has been very positive from an industry point of view, as it does give the opportunity to expedite product to market faster than ever before. It even opens the door to potential applications not reliant on CE being able to enter the Australian market.
But what we’re yet to see is the what’s next?…..
We’ve seen a growing trend of communications between the global regulatory heavy weights where they are notifying each other of specific events or situations. Everything from significant recall actions where regulators are now considered part of the internal regulators publication lists, keeping each other closely linked to all that is happening in their own jurisdictions. We’ve also seen increases in regulators communicating complaints and adverse events across multiple jurisdictions. This generally results in the local regulator approaching the local representative asking quite sticky questions, such as why they were not notified of an incident, or any similar incidents.
With this increase in post market communications and scrutiny, it’s becoming more and more imperative that Manufacturers work closely with their local representatives to ensure both parties are aware of what’s happening. Keeping each other informed can help prepare you for any potential questions that arise following an adverse event or incident, or post market activity. Like most agencies, there is an expectation and process to manage such circumstances, and determine what involvement, if any, the regulatory agency needs to have. This is normally determined by the manufacturer and is done through a risk assessment, with a final rationale as to why there was or was not any involvement for the regulator.
Considerations of Actions
What also needs to be considered is the follow on requirements from any corrective action the manufacturer determines is needed. We normally see this in areas such as updated user documentation following a customer complaint or adverse event. This is sometimes considered the simplest way to manage complaints or incidents in the Quality System. Manufacturers need to strongly consider such an action, as although the result will assist in closing out a corrective action, or at least assist in mitigating it, it may also inadvertently result in a Post Market Corrective Action such as safety alert or recall. It’s also easy to fall into the trap that if a recall or regulatory notification is not required in the manufacturers jurisdiction that it won’t be required in the rest of the world. Generally, this assumption is wrong. Part of your regulatory considerations with any change to documentation needs to be how the communication is circulated, and what the local regulatory requirement is with regard to notification to customers. It also needs to consider the pre-market aspect where it may affect product registrations and approvals. This small failure to plan can ultimately result in a huge amount of damage control needed by the manufacturer once any of the regulatory agencies start to communicate amongst themselves.
The old saying, “failure to plan is a plan to fail” cannot be more true under these circumstances. Ensuring you have open dialogue with your local regulatory representatives will help ensure the manufacturer has a clear understanding as to what is expected in the specific jurisdiction. We cannot always rely on the written regulation to determine a pathway forward, as in many countries there are specific nuances that may come into play. Having local staff and/or expertise can assist in understanding these local requirements, and better yet, can also in some instances provide direct communication with the regulator on your behalf.
An additional takeaway to the above, It’s also important that if there is some level of notification needed, that the regulator is kept up to speed. This can help avoid any inadvertent release of information from the regulator which, although may have been agreed to, was not yet ready to be circulated. It also helps reduce the risk of any surprises from your own regulator, or any others you may be managing. Most regulators have clear inhouse processes and policies on how to handle such situations, and most are more than willing to have the discussion on how to handle the situation. Most importantly, if you remain transparent with the regulator, it generally works in your favour in managing the outcome.
If you’ve found yourself struggling with the post market requirements, communications with any regulatory agency, or just wish to have a brief discussion to better understand specific regulatory actions or requirements, we’d be happy to have confidential call with you.
Need Post Market support? We work with you to ensure proactive, continuing compliance and manage emerging issues to minimise disruption to your business. To book a free consultation, please email us at email@example.com or call our office on +61 2 9906 2984.