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Warning: This medical device literature review may contain traces of LBS

Medical Device Literature Review

With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in conjunction with the existing Australian Regulatory Guidelines for Medical Devices (ARGMD).

Clinical evidence for devices can vary depending on the class of the medical device. It is common for manufacturers to provide a CER derived from a variety of sources, such as clinical trials, literature reviews and/or post-market data for the proposed device. It is also common to collate data from equivalent or similar devices as long as there is an explanation of how evidence for the equivalent or similar device is applicable to the proposed device. Most of the time, literature reviews form a part of the CER.

The features of a literature review provided in this draft clinical evidence guideline closely resemble those for a literature-based submission (LBS) for medicines, such as:

  • A documented methodology, which captures published and unpublished scientific literature, both favourable and unfavourable,
  • A search protocol, which would include the database searched, search terms and limits used, inclusions/ exclusion criteria, to ensure the search can be replicated,
  • A selection strategy, which involves examining the quality of the literature, including the design of the study/ investigation, quality and completeness of the data reported, its scientific impartiality, and validity of any conclusions drawn in the paper,
  • Critical analysis of the data by an expert in the therapeutic area, rather than a summary of each literature article and a general conclusion at the end.

Some of the common errors made in CERs have also been highlighted by the TGA in this draft guideline.  Errors tend to relate to the proposed literature search strategy, such as the lack of a comprehensive literature review with documented methodology, an inadequate demonstration of substantial equivalence between reference device and the device under review, absence of critique or discussion of the evidence or its validity.

There is no need to obtain prior TGA approval for the proposed search strategy, however based on the above criteria, the TGA will be expecting a CER that delivers strongly on the quality of data.

The TGA consultation for the draft clinical evidence guideline closes COB on 10 June 2016, so make sure you take a look and provide input where necessary.

 

For assistance developing a suitable CER for your product, please contact our expert Regulatory Services team on +61 3 9251 0777.

This article was written by Wai Zin Wong, from our Regulatory Service team.




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Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market

exploding-idea

As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding the right resources to help us make informed decisions that suit our needs.  Building a successful commercialisation strategy for a new medicine is no different and requires a plan that must include the right resources and knowledge.

Introducing a novel treatment into Australia requires the sponsor to align with governance factors that shape the local pharmaceutical industry. An in-depth understanding of the current regulatory and reimbursement environment is critical for success. As such, planning for product launch should begin with the development of a cohesive strategy that occurs long before the submission of a regulatory registration dossier or government reimbursement application.

Consequently, resourcing and investing in accurate market insight advice specific to the Australian market can be invaluable. Government authorities are demanding more data than ever before, so coordinating relevant activities in the lead-up to launch cannot be underestimated. Market insight advice can formulate valuable assessments that will ensure any key gaps in various inputs are identified and filled which is critical to strategic decision-making. Market Insight professionals are similar to a knowledgeable party planner who meticulously researches and plans to bring the most useful and relevant resources together to set the scene and create a successful event.

Of course, it does not stop there, optimising a planned strategy also requires timely and appropriate execution. There is no point in the DJ arriving three days before the party, just as it can be fruitless to attempt a cost-effectiveness analysis with incomplete data or an unconfirmed indication. At the same time, it is also wise to show up a little early to scope the scene and identify where information is missing. As the demand for detailed clinical and economic evidence increases, a timely market access strategy allows a sponsor to paint a clear picture of the new treatment’s value offering to decision-makers at the earliest feasible point, having addressed any previously identified shortcomings in the acquired data.

Capturing clinical data that encapsulates the needs of both a regulatory and PBAC application is a worthwhile consideration prior to the drafting of a TGA/PBAC parallel process submission. Each individual TGA and PBAC application should be well structured and complement the other to form a compliant, comprehensive and cohesive submission for the proposed product. The timing of these types of submissions requires effective pre-planning and communication, a process that is significantly strengthened by synergy between the Market Access and Regulatory Services experts involved.

Just as a party host should be checking in to make sure that hot food is continuously available for guests, for commercialisation, inputs should be checked for accuracy and completeness. As a medicine gets closer to launch, marketing strategy development, pricing considerations, and cost effectiveness modelling help support reimbursement goals. When accessed through a single source such as Commercial Eyes, coaction is assured between the experts working within these distinct workflows, helping to harmonise and strengthen each of the applications required to achieve the optimal launch of a medicine on the Australian market.

Early implementation of a well-conceived strategy, specific to the needs of the product, will benefit both registration and reimbursement applications. As with any successful event, a commercialisation strategy must be well planned and properly executed to achieve optimal results. Engaging Commercial Eyes opens a specialised avenue to multiple experts in all areas of Market Insights, Market Access, and Regulatory Services. As a unified team, we can offer an integrated approach to any product launch and help you effectively manage the entry of your new drug into the Australian marketplace.

 

Commercial Eyes offers a full and integrated suite of consulting services across Market Insights, Market Access, and Regulatory Services. Call us on +61 3 9251 0777 for our insights into commercialisation strategies for healthcare products.

This article is co-written by our Market Access team and Matthew Douglas from our Market Insights team




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Data and Safety Monitoring of Clinical Trials

Safety Monitoring

Randomised clinical trials for medicines and medical devices are progressively being monitored for safety and other interim results by both Sponsors and Contract Research Organisations (CROs). There are a variety of methods to aid in proactive monitoring and gauging of patient safety and risk, including the utilisation of independent panels of expert physicians and biostatisticians, or what are known as Data Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs).

DSMBs/DMCs have as their top priority the ongoing assessment of subject safety during the course of a trial where subjects are exposed to heightened risks of trial participation due to the use of experimental medicines and/or medical devices.

The importance and growing popularity of monitoring panels has been recognised, evidenced by the FDA’s guidance and recommendations to Sponsors regarding when such committees should be convened as well as a general operational framework for each member’s role and responsibilities.  In order to maintain an independent unbiased role in their oversight of a trial, the physicians and biostatisticians of a DSMB/DMC may not have any fiduciary association with the Sponsor and may not be operationally involved in the trial as steering committee members, investigators or as the active study biostatistician.

A common example of when a DSMB/DMC panel may be convened surrounds central adverse event adjudication. Another area where DSMB/DMC panels play a key role is concerning trial protocols. Before a trial protocol is finalised for regulatory approvals, the DSMB/DMC may participate in a review of the trial protocol to provide feedback to the Sponsor as to operational characteristics that may be problematic and lead to subject safety and/or trial scientific integrity concerns. If there are formalised interim stopping rules defined in the trial protocol, these will be reviewed so that all parties understand the timing and mechanisms by which these decisions will be made.

Following are some of the ongoing safety and scientific integrity questions that a DSMB/DMC may need to consider:

  • Are subjects being exposed to reasonable risks given the scientific research that is being conducted?
    • Are there unexpected events not initially envisioned at the outset of the trial?
    • Are there evolving safety signals that might suggest that subjects in the trial are being exposed to an elevated level of risk and, with an eye toward the future, is it reasonable to continue the trial given the projected risks to subjects yet to be enrolled?
    • If continuing the trial is reasonable, a DSMB/DMC may make recommendations to the Sponsor to communicate safety related issues to the study steering committee, the investigators and even the FDA to raise awareness
    • If the safety issues are material and the risks to subjects are no longer acceptable, the DSMB/DMC can make a recommendation to stop the study early due to these concerns
  • Are the a priori assumptions that led to the power and sample size calculations in the trial protocol still valid?
    • Is the observed data deviating from these assumptions, perhaps leading to the need for an interim sample size re-estimation which would most commonly be an increase in the enrolment target?
    • Can the new enrolment target be achieved?
  • Is there new data from an external source (e.g. a similar or clinically relevant trial) where the results that have become available suggest that it would be unethical to continue the trial being monitored?

In trials where there are formalised interim stopping rules, these must be pre-defined in the trial protocol. These stopping rules would be derived through detailed statistical methods.

  • Stopping for Safety
    • Predefined criteria for the incidence of serious adverse events, especially if they are deemed to be treatment emergent/related or are indicative of treatment failure. These are typically expected events, which are occurring at rates that raise questions about the risk/benefit balance of the treatment(s) under study
  • Stopping for Efficacy
    • Predefined criteria, which would demonstrate that the benefit observed in the treatment of interest is sufficiently large, that to continue the study to its logical conclusion would not alter or reverse this finding
    • Stopping the study for efficacy on an interim basis would have stricter than typical p value thresholds for statistical testing (e.g. p ≤0.001 as opposed to p ≤0.05) to control for false positive (Type I) errors, and would account for multiple looks at the data
    • Ifthe criteria are met, stopping would reduce the required sample size for the study, reducing risks to subjects not yet enrolled and address the ethical questions, for example, of continuing to treat subjects with an alternative that is now demonstrably inferior. It would allow the Sponsor to proceed to regulatory submissions earlier and at a lower cost than originally budgeted
  • Stopping for Futility
    • Predefined criteria that would indicate that there is a lack of a clinically meaningful benefit attributed to the treatment of interest. If the study were to continue to its logical conclusion, the probability that this finding would be altered or reversed to demonstrate a benefit is sufficiently low (typically <10%) as to raise ethical concerns to continue.

 

Commercial Eyes’ experienced Clinical Development team can help you navigate the data and safety monitoring requirements of your clinical trials. Call us on +61 3 9251 0777 to discuss your needs.

This article was written by Ric DeGaris, a member of our Clinical Development team.




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Are you eCTD ready?

eCTD in Australia

eCTD Submissions

Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an important milestone for the TGA in recognising eCTD as an acceptable (and preferable) submission format and is supportive of the broader government policy for digital transition.

 

Recent developments

As an incentive for sponsors to adopt the eCTD format, the TGA has recently commenced a pre‑submission pilot for certain types of new Category 1 applications (Type A and Type D) submitted as a validated eCTD sequence. The intention of the pilot is to decrease the pre‑submission workload for sponsors and to reduce the overall registration timeline by at least one month. Participation in the pilot is optional and represents an excellent opportunity to take advantage of an expedited evaluation pathway for eligible applications.

 

Advantages of eCTD

Electronic dossier formats (eCTD or NeeS) have a number of advantages over paper based submissions including:

  • Reduced costs associated with producing, checking and Storage of paper dossiers
  • Enhanced navigation between documents
  • Greater search functionality

Some additional benefits which are unique to eCTD include:

  • Lifecycle management of documents
  • Ability to reuse files
  • Cross-referencing to previous sequences

While the eCTD format is not currently mandatory in Australia, it is only a matter of time before the TGA joins other global regulators in mandating eCTD. Given the substantial benefits and advantages of moving to eCTD, and in order to start developing familiarity and experience, sponsors should strongly consider introducing it to their regulatory processes now to ensure that they are prepared in advance of any changes to TGA policy. 

 

Conversion to eCTD

Submitting the initial registration application in eCTD format is the most convenient and logical approach to maintain the full product history in a single electronic location. For currently registered products or applications under evaluation that have been submitted in formats other than eCTD, converting a dossier will involve planning, and the appropriate timing will depend on ongoing regulatory activities, the status of the dossier and other commercial priorities. Submission of an eCTD baseline is highly recommended by the TGA when converting from paper or NeeS format and the baseline sequence is essentially a reformat of previously submitted CTD documents. Creating an eCTD baseline is a valuable exercise from both a regulatory and compliance perspective.  Although initially it may seem daunting, the benefits to your regulatory maintenance program through improved document lifecycle management will quickly be realised.

 

To discuss how Commercial Eyes can assist you with all of your eCTD needs call us on +61 3 9251 0777.

This article was written by Danielle McLennan from our Regulatory Services team.

 




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Commercial Eyes Recruiting: Medical Information Assistant

Medical Information Assistant

Commercial Eyes has an exciting opportunity for a switched-on assistant

to join our team on a casual basis to provide administrative support to the Medical Information team in respect to meeting client demands and expectations.

 

To be successful in this role, you will have…

  • Tertiary qualification
  • Australian citizenship or permanent residency
  • Demonstrated computer experience with Microsoft Word, Excel, Access, PowerPoint and Outlook
  • Highly developed communication and customer service skills
  • Excellent organisational, time management and problem solving skills
  • Experience with database management (preferred)

Key responsibilities include:

  • Providing administrative support to ensure Medical Information operations are maintained in effective, up-to-date and accurate manner
    • Word processing, creating spreadsheets and presentations as required
    • Organising and storing Medical Information contact logs in client specific folders
    • Managing offsite document storage for Medical Information
    • Ensuring contact logs are printed and allocated to each team for daily enquiries
    • Preparing and sending outgoing faxes, mail and courier parcels
    • Transferring non-medical calls or collecting caller details to forward to other CEPL departments
    • Ensuring office stationery are always available for Medical Information
  • Assisting the Project Team Leaders with month end duties and reports
  • Maintaining a database of Medical Affairs activities
  • Providing basic support in processing of medical information enquiries
  • Performing other related duties as required
  • Billing a minimum of one third of work time to clients

 

In return…

This role is a rewarding one that offers all the traditional benefits of employment, such as a competitive salary, a supportive and respectful culture, a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

 

For more information about this role, please visit our Seek ad.


Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad.




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Multi-criteria decision making – How can non-health attributes be considered and valued?

Pressure is mounting on decisions to recommend and continue funding health technologies. Concerns around the rising cost of new medicines, an ageing population with greater resource utilisation, federal and state healthcare budgetary constraints, and an increasing dependency ratio (the ratio of individuals who are not in the labour force compared to those who are and paying tax) are significant contributors to that pressure.

Multi-Criteria Decision Making

As a developed country we are not alone facing the pressures of allocating increasingly limited resources to maximise health gains from our healthcare system. However debate in other countries with publically funded centralised healthcare systems has focused on refining how the value of new health technologies is assessed and translated into price. The premise of this has been to provide manufacturers with greater certainty around their investment and market access decisions.

Reforms in Australian healthcare policy have seemingly focused on the affordability of currently reimbursed products. The first of the 5% statutory price reductions began on April 1 2016 through the PBS Access and Sustainability Package for those molecules which have been in the F1 formulary for five years or more. This now adds a time component for which a molecule (irrespective of indication, timing of patent expiry or data exclusivity periods) can be listed before reductions in price are legislated, on top of price disclosure reductions legislated as the molecule shifts to the F2 formulary and generic medicines become available and compete for market share.

While policies that impact the affordability of medicines are applied post-listing, the initial benchmark assessment of value occurs during the submission phase. Demonstrating value to the PBS for new medicines is required throughout HTA processes, firstly through an assessment of the clinical effectiveness and safety of new medicines against a comparator in clinical trials. Then, depending upon these outcomes, the incremental clinical performance must be explained through a cost-minimisation or cost-effectiveness/utility analysis by considering health effects and healthcare resource implications.

Though attention has begun to turn to the inclusion of non-health attributes such as consumer experience/preference, it is not clear how these additional attributes will be incorporated into the decision making process. For example, whether they will be explicitly incorporated into a cost-effectiveness or cost-minimisation analysis or if they will be considered as additional criteria outside of the evaluation process. Perhaps there will be a standard framework for which information is assessed but how will that be standardised and communicated?

Similar issues arise in relation to existing consideration of life saving drugs and the role of the rule of rescue.

Over the next few months, the Guidelines Review Steering Committee will review the public consultation submissions issued in response to the new draft PBAC guidelines for the assessment of medicines. We can only hope that amongst their considerations they:

  • Review whether deliberative decision making is appropriate for consistent and transparent outcomes, and
  • Consider the array of decision making frameworks that fall under the umbrella of multi-criteria decision making (MCDA) which can be used to explicitly link different attributes, and effectively and transparently communicate outcomes.

As part of a broader process, it would be greatly advantageous to further consider, what relevant non-health attributes ought to be included; how they will be measured; how they will be valued; how the value of individual attributes will be aggregated and how this will be linked to an assessment of a medicines overall value.

 

The expertise and experience of the Commercial Eyes Market Access team is at your disposal to help you navigate the PBAC Guidelines for the assessment of medicines. Call us on +61 3 9251 0777.

This article was written by Peter Moore, our Health Economics and Market Access Manager.




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Keys to off-label communications

The TGA and the Medicines Australia Code of Conduct are very clear on the appropriateness and dissemination of off-label information to HCPs.

Off Label Communication

In a post-marketing setting many products gather a body of evidence surrounding their use outside of the approved labelling.  This evidence may include alternative indications, dosage, administration methods or target populations (e.g. paediatrics). This may be through an unexpected effect observed in a clinical trial, an excited letter to the editor from a surprised doctor, or a researcher attempting to fill a void in the market not adequately covered by existing therapies. Regardless of how or why the body of evidence is formed, it is essential for sponsors to know how to use this information to formulate responses to spontaneous requests from healthcare professionals. Here are some of the vital pieces of information you need to know:

  1. Know your regulations

    It is absolutely essential that company employees are aware that there are regulations and associated penalties with regards to the advertising of off-label information. The Therapeutic Goods Act is clear that it is an offence to advertise therapeutic goods for an indication that has not been accepted as part of its listing.

    Whilst advertising of off-label information is not permitted, the provision of information to HCPs is allowed through the Medicines Australia Code of Conduct (section 1.4) which describes who can respond.

  2. Differentiate solicited vs. unsolicited requests

    Off-label information is never to be promoted/advertised by a company.

    • Members of the commercial team, e.g. sales representatives, must not pursue any conversation regarding off-label use.
    • Company representatives must not offer, prompt or suggest off-label information.
    • Company representatives must pass the request to the appropriate Medical department for a response.
    • Companies must only respond to healthcare professionals.
    • All responses must be unique and directed to a specific healthcare professional (so no generic “Dear Doctor” letters are permitted).
  3. Respond through appropriate channels

    In all cases, responses for off-label information should be prepared and sent via the medical department. Under no circumstances should the information be supplied by a member of the commercial division (e.g. sales representatives or product managers). This makes it clear to an external observer that the company is not promoting the off-label use of their products.

  4. Use all of the Evidence

    In responding to a request, the medical department should consider the following in their response:

    • Use peer reviewed literature from recognised medical databases like Medline or Embase.
    • If summarising literature, clearly define the level of evidence in the paper. A body of evidence consisting of a single case study and an animal investigation must be presented as such.
    • Be neutral – present all studies regardless of outcome and eliminate bias in your response.
    • Do not conclude. The purpose of a response is for the healthcare professional to evaluate available evidence and form a clinical opinion. A conclusion may be viewed as a form of promotion.
  5. Disclaimers

    Whether you’re making a phone call or sending a letter, be sure to:

    • Include excerpts from, and a full copy of, the approved labelling (for example, the product information or instructions for use).
    • Clearly state what the product is approved for and that the information that is being provided is not approved.
    • Confirm that you are responding to an enquirers unsolicited request for information
    • Confirm that the use of the product in an unapproved way is at the clinical discretion of the healthcare professional, not a recommendation from the company.

 

Our medical department is highly experienced in responding to requests for off-label information. Call us on +61 3 9251 0777 to discuss your Medical Service’s needs.

This article was written by Anthony Anselmo from our Medical Services team.




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Contemporary Economic Modelling – State of the Art

Contemporary Economic Modelling

The Albert Einstein adage, Everything should be made as simple as possible, but not simpler.” was the overarching principal that economic modellers should adhere to, communicated in the quarterly workshop session “Contemporary Economic Modelling”, attended by members of Commercial Eyes’ Market Access Team. The session was held by the Australian Chapter of the International Society for Pharmacoeconomics & Outcomes Research (ISPOR-AC) at the University of Technology’s Aerial Function Centre in Sydney on the 17th of March 2016.

Andrew Mitchell, Advisor to the Department of Health, chaired the morning session entitled “Advanced Modelling techniques” and echoed this sentiment stating that his favoured term for modelling is “parsimony”.  A check of the Merriam-Webster dictionary definition of parsimony suggests this viewpoint could be considered rather apt by a number of the attendees given the current reimbursement environment. The session included a series of practical demonstrations by leading experts on microsimulation and discrete event simulation modelling methods, as well as a demonstration of Anylogic®, a simulation software tool which can provide enhanced visual information on modelling outcomes.

Professor Jon Karnon of the Economics Sub-committee, insightfully reminded attendees that the need for individual-level modelling methods are only on a “as needs” basis, as the proposed new PBAC Guidelines (v. 5.0) requires applicants to justify and support the need for individual-level, in place of a cohort-based model.

The mid-morning workshop provided a platform for new investigators to present a 5-Minute research snapshot of their work.  Speakers covered a wide range of topics including the cost-effectiveness of rotavirus immunisation, primary prevention of breast cancer using tamoxifen, sentinel lymph node biopsy in patients with cT1-T2N0 oral cancer, and cost-effectiveness of rituximab maintenance therapy in patients with follicular lymphoma.  A key tip from an ex-evaluator from PHARMAC highlighted the importance of accurate transcribing for model results to the submission; seemingly obvious, but an error which has appeared to have caught out more than one sponsor in the past.

The afternoon session, entitled “Economic Modelling of Health Outcomes” included four speakers who presented on the use of real world data in cost-effectiveness modelling and exemplar models on healthcare interventions and new diagnostic techniques. Simplification of complex therapeutic areas, distilled to relatively simple decision analytical models, were appreciated by external discussants, including the ESC’s Jon Karnon, further illustrating the merit of simplicity.

Albert Einstein

Overall, the day served as a strong refresher in the value of simplicity in a complex and technically challenging area, in which modellers can often be trapped in the detail and forget the fundamental idea of what the model is wanting to communicate.

 

Our Market Access team has a number of senior health economists experienced in advanced modelling methods to communicate the economic value of your pharmaceutical or medical health technology to reimbursement agencies. Call us on +61 3 9251 0777 to discuss your Market Access needs.

This article was co-written by Daniel Tan, Megan Bohensky and Peter Moore from our Market Access Team




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Commercial Eyes Recruiting: Market Insight Manager

Market Insight Manager

Commercial Eyes has an exciting opportunity for a Market Insight Manager

Due to the growth and structural change in the Commercial Eyes business over the last three years, we are hiring a Market Insight Manager on a full time basis, to be based in our Melbourne office.

 

An important focus of this role is to manage and develop direct reports.  This is a challenging senior role in the organisation, encompassing a range of responsibilities including:

  • Provision of high quality Market Insight consulting services and advice to clients across the pharmaceutical, biotech and medical device sectors. 
  • Manage the performance and development of the Market Insight team including performance reviews, skills and knowledge development needs and progression opportunities, and management of resource and staff welfare issues. 
  • Proactively seek project and consulting opportunities through a range of business development activities.
  • Building strong interpersonal networks across the life sciences sector and drawing on these to identify potential short and long term business opportunities for CEPL.
  • Provide assistance and support to the Director, Market Access in areas of the business unit management.

 

Budget and Line Management Responsibilities

– subject to the experience and interests of the successful candidate, it is expected that this role would have line management responsibilities for approximately 3-4 members of staff and contribute to the formulation of annual financial objectives and budgets.

In return….

This role is a rewarding one that will offer a competitive salary to the right candidate and a rare opportunity to lead a dynamic and successful team. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies. 

 

For more information about this role, please visit our Seek ad.




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Is our product a medicine, a device, a cosmetic, an OTG or a food… and what could it be?

An increasing number of traditionally pharma/device companies are crossing boundaries to offer their patients a product portfolio spanning several product categories. Examples include medical devices that support delivery and tracking of patient medication as well as cosmetic and sunscreen line extensions that supplement a medicine range. Other therapeutic goods (OTGs) include tampons and disinfectants, however disinfectant hand rubs are regulated as medicines.   Additionally, the desire to extract more and more health benefits from our food has resulted in the food/medicine boundary being pushed further than ever before. 

So what is it about my product that defines its regulatory pathway?

Regulatory Pathway

The most appropriate regulatory pathway is not always a straight forward decision, however is likely to significantly impact the contents of your supporting technical file, especially where products are classified differently in different countries. If you are not building the correct supporting technical file or medicine dossier during the planning and development phase you might find you need to modify your labels claims or undertake rework at a later date to meet regulatory requirements. 

There may be several regulatory pathways that may apply to your product, depending on how it is intended to be used, so it’s important to bed down the target indication/intended purpose early.

Be careful with cosmetics making therapeutic claims as these may require a medicine listing on the Australian Register of Therapeutic Goods (ARTG). Such cosmetics may be arriving from countries where GMP evidence is lacking. 

The recent update to the Food Standards for Australia and New Zealand (FSANZ), effective 01 March 2016, provides users with long-awaited clarity and a more user-friendly format. However, again, be careful with claims that cross the therapeutic barrier into listed medicines.

Where deliberate or unintended, some alterations to labels claims can turn a medicine into a cosmetic or food and vice versa.

Labelling and advertising regulations can also differ between each of these product classes, creating a tug-of-war between local compliance and global harmonisation. 

 

Should you find yourself in such a predicament, and need some assistance navigating the various regulatory pathways, Commercial Eyes would be happy to share our experience. You can reach us on + 61 3 9251 0777.

This article was written by our Director, Regulatory Services, Jeanette Lodge




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