OTC INSIGHT North America Blog: Canada Unveils New OTC Regulations

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In June 2014, Federal Health Minister, Rona Ambrose, announced her intention to create a new set of regulations for OTC products. Now the Minister has released the framework for moving OTCs and disinfectants out of the regulations covering prescription drugs where these products currently reside.

The proposals are wide-ranging and designed to give the government more flexible tools to manage the licensing of products intended for self-care. New tools have been undergoing pilot testing and the results were positive to the extent that the new rules will allow the implementation of some key market access approaches. This would include the adoption of monographs, which could be used to grant a product licence when a manufacturer attests to those standards. The monographs would be incorporated into regulations by reference, making then easier to adapt to changes as needed.

There will be five pathways to market authorisation. Including the compendial approach described above, there will be a stream for non-compendial submissions (ingredients that are not found in the monographs), administrative changes (e.g. manufacturer’s name change), prescription drug status switch (removal of an ingredient from the prescription drug list) and innovative non-prescription drug filings (e.g. novel ingredients and perhaps some types of switches).

The proposals also make reference to incentives for innovation and data protection but fail to provide much detail on what this would look like. However, it does appear that there is an intention to encourage switch through some form of market incentive.

Some things won’t change much. The good manufacturing practice rules will stay largely as they are. This will facilitate the use of mutual recognition agreements for import and export that have been developed over the past several years. Evidence for safety, quality and efficacy will remain and the evaluation process will be driven by a relative risk assessment and mitigation approach.

Some aspects of the proposal may have broader implications. For example, there is a suggestion to remove the prohibition on sampling for OTCs and allow sampling under prescription conditions. Since natural health products regulations are not in the scope of this project, the sampling prohibition would continue to apply to natural health products. While natural health products companies do sample and this prohibition isn’t generally enforced by Health Canada’s Inspectorate, there could be some noise about a level playing field on this matter.

There are numerous Easter eggs in these proposals and they will become more apparent as the consultations evolve.

For updates on this story, make sure you subscribe to OTC.NewDirections. There will also be in-depth analysis of these regulations in the upcoming December issue of OTC INSIGHT North America.

December 2013 Editor’s Comment – OTC.NewDirections

DaveNDheaderAs the festive season fast approaches, several medicine agencies are reminding marketers of deadlines for certain marketing authorisation submissions. The European Medicines Agency has an imminent deadline for Type-IA variations (a change that has only a minimal effect, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned), while medicines agencies in Belgium, Denmark and Latvia have also issued reminders about upcoming deadlines. For more details, see tomorrow’s edition of OTC.NewDirections.
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OTC.NewDirections Editor’s Comments: 30th October 2013

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Product safety is one of the key themes in our latest edition of OTC.NewDirections, with two stories related to supplements in Australia. The country’s medicines agency, TGA (Therapeutic Goods Administration), has announced a review of oxedrine (synephrine) and caffeine, both of which are ingredients commonly found in energy and weight loss supplements. The issue of caffeine’s safety has become a hot topic for regulators across the world, notably in the US, where the FDA has been reviewing 1,600 AERs (Adverse Event Reports) for caffeine-based foods and supplements.

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October OTC.NewDirections Editor Comment

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Now two years since the FDA issued its draft guidance on the regulation of mobile medical apps, the agency has now published its long-awaited final guidance. Marketers will be relieved that the FDA has said it will only focus on the small proportion of apps that function like medical devices, such as those that turn smartphones into blood glucose monitors or electrocardiography machines, rather than all healthcare apps. Innovators in the field will appreciate the clarity that this guidance brings and the fact that the FDA will not require clinical trials for new apps that resemble medical devices already on the market.

In the latest edition of OTC.NewDirections, we reveal more on this story and provide a round-up of various other developments affecting medical devices over the past fortnight. These include new EU measures on medical devices in the wake of the breast implant scandal that broke in 2010, as well as an FDA ruling on unique device identification (UDI) systems and the agency’s effort to boost development of medical devices for children by awarding various grants.

Our latest edition also features expert commentary from our partners JensonR+ on a wide range of topics from restrictions on analgesics in Denmark, to homeopathy claims in the UK and classification changes for glucosamine in Finland. For more on these stories, and the latest scientific findings on supplements, make sure you subscribe to the bulletin.