Products impacted by this (Annex A of the bulletin) will no longer require identity testing after receipt in Canada and will also not be required to undergo confirmatory testing in the interim during this pandemic. Importers, however, will still be responsible for ensuring products meet their required specifications and were manufactured under Good Manufacturing Practices. This will give importers of products impacted by this the opportunity to directly ship from fabricators to retailers, as long as the importers release the product before being shipped via review of the necessary documentation and test results as well as ensuring quality agreements are put in place between the foreign manufacturer, importer, and receiver of product.

It should be noted that this update to current low risk non-prescription drug import regulations does not exempt the responsibility of Canadian Quality Control department to ensure all products comply with Canadian regulations. These updates simply minimize any delays that may occur in the process of importing non-prescription drugs during these troubling times.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post Less Testing for Imported Low-Risk OTC Drugs – Temporarily appeared first on Focal Point.

The impact was first seen in China due to the lockdown in Wuhan, preventing citizens from leaving their homes. A large part of the cosmetic market is in China, but due to the lockdown, sales of cosmetic products have declined. Also, as many cosmetic companies rely on Chinese suppliers for their cosmetic materials, a delay or decrease in production has been seen by many. Finally, the medical device industry has seen a decrease in revenue due to fewer non-emergent procedures in China. This drop in elected procedures has caused lower than expect revenues for medical device companies in China.

Most recently, there have been many cancellations of public events, such as conferences and tradeshows, to prevent further spreading of coronavirus. This has involved the first cancellation of the Healthcare Information and Management Systems Society in 58 years, which was to take place in Orlando, Florida. This event was expected to have many health care professionals in attendance, and therefore the risk was too extreme to rightfully have the event. Another cancelled event was South by Southwest, a music, film and technology festival which was to take place in Austin, Texas and has been known for featuring the latest medical devices. Both events are currently exploring the possibility of hosting a virtual event to make it up to the disappointed attendees.

Other events have been more hopeful and have postponed to a later date. For example, in-cosmetics Global, an event for personal care ingredients, was to take place in Barcelona, Spain at the end of March, but has now been postponed to the end of June. However, there has been no prediction or expectation for the coronavirus to subside. Therefore, it is difficult to say if postponing, cancelling, or taking an event virtual is the best way to handle this unforeseen circumstance. One thing we can be sure about, this impact on the cosmetic and medical device industries will continue until coronavirus becomes less prominent.

For more information on the cancellation/postponement of the mentioned events, please visit South by Southwest, in-cosmetics Global, and Healthcare Information and Management Systems Society. For the most recent information on COVID-19 please visit the WHO.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post COVID-19 Impact on Cosmetic and Medical Device Industry appeared first on Focal Point.

Similar to QRA, QRA2 was revised through the input of dermatologists, academics, industry personnel, and stakeholders. QRA2 is a revised methodology for quantitative risk, focusing more on aggregated exposure than its predecessor. By focusing more on aggregated exposure, the exploration of the same fragrance ingredient contained in different products is investigated using databases on real-life product use and habits in a statistical model. This new methodology provides a more realistic look at fragrance ingredients and skin sensitization.

These large changes to the IFRA Code of Practice were necessary for multiple reasons. First, the amendments allowed for harmonization of skin sensitization and systemic toxicity endpoints. Secondly, while the changes maintain the core values of human health and maintaining the environment, the amendments allow the consideration of computation toxicology tests and alternatives to animal testing, wherever possible. Global fragrance manufacturers will need to comply with these changes by February 10 2021, for new products, and by February 10 2022 for pre-existing products. This time frame allows corporations an opportunity to reformulate if necessary. IFRA plans on holding training sessions and webinars for members, to aid in a smooth transition. As well, IFRA will provide a list of service providers who can help with testing and reformulation. For more information on this subject please visit the websites of CosmeticDesign Europe, ecomundo, UL, and the IFRA.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post 49th Amendment to the International Fragrance Association Code of Practice appeared first on Focal Point.

Patent protection is often considered the Holy Grail of innovation. If you have a shiny new invention, it will benefit from long-term protection. A patent can allow you to build your business and hopefully sell it and make you very rich. But like most things, there are shades of grey.

Say you are able to get a patent. How strong is it? Can a smart person work around it? And even if your patent is rock solid, that does not stop copycats. A patent only allows you to sue them for infringement. That’s a huge misunderstanding for many new innovators. What if you launch and five copycats appear on the market? You need deep pockets and a talented legal team to deal with this. I have seen innovators abandon their patents because they didn’t have the funds or stamina for the litigation.

Going back to the entrepreneur with an old molecule. Many of the regulatory hurdles had been overcome by previous innovators. The few remaining ones seemed surmountable. I have seen projects like this become hugely successful with rapid scale up and sales execution. If copycats arrive, the entrepreneurs continued to innovate with product improvements, line extensions, and new sales and distribution channels.

Sure, a rock-solid patent is great to have but it’s not the only option to make you a successful innovator.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Patents” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

The post Patents: Misconceptions and Watch-Outs”. appeared first on Focal Point.

This new in-lab testing method not only eliminates the need for animal testing by providing the opportunity to analyze bioactive ingredient uptake in hair and skin but has many other benefits as well. These new hair and skin models provide insight into a formulation reaction to skin or hair, exploration into diffusion rates, and interactions between materials. The models also offer the inspection of ingredient-ingredient reactions both during storage and application. Finally, the models allow the study of ingredient reaction and toxicity at a molecular level. Because the new hair and skin models can be used for such extensive testing, there is little to no need for animal testing at all.

On top of the great amplitude of testing opportunities, the new models allow shortening time in the cosmetic design process. These models were created with the idea of quick in-lab testing by being compact. As well, the extensive testing options available with these models, permits the focused observations of single or multiple ingredients in the lab. By being compact and opportunistic in its testing methods, these models permit the rapid elimination of potential options, which abolishes the need for large scale testing and repetitive trial and error. This in turn reduces the overall design process in the cosmetic industry.

In the end, the new hair and skin testing models offer an important alternative to animal testing and can reduce time in the design process for many cosmetic products. With incredible benefits that models like these provide, it is exciting to see the bright and cruelty-free future of cosmetics. What a great start to 2020 for everyone involved in the cosmetic testing community.

To see another article about this topic, please click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post New Hair and Skin Models Indicate an Animal Friendly Future appeared first on Focal Point.

When it comes to complaints, these are things I look at:

1. The seriousness of the complaints. In my world of regulated products, these usually pertain to adverse reactions, issues of health and safety etc.

2. The percent of complaints to units sold.

3. Trends. Are complaints going up, down, sideways?

In the case of my recent sleepless entrepreneur, none of the complaints was particularly serious. In terms of the absolute number, a dozen seemed like a catastrophe. But it turns out that there were over half a million units sold; the complaint rate was about 0.002%, miniscule. In terms of trends, it was a predictable steady growth of complaints as the business expanded. Time for a good night’s sleep!

The other advice I give to entrepreneurs is if you are not getting complaints or at least some type of feedback, I would be concerned. Unless you are an absolute genius, your product will launch with further optimization needed. All within reason of course. So I say, embrace your complaints. Master dealing with them. And use them as learning for your next generation innovation.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Complaints” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

The post How to Handle Complaints Made About Your Innovation appeared first on Focal Point.

So, how does it work? The laser ultrasound machine consists of two lasers; one that emits a light wave and one which receives a soundwave. The conversion from light to sound waves occurs on the skin. The light wave causes the blood vessels in the skin to expand. The body then cools the blood vessels causing them to shrink. This rapidly repeats as continuous light wave approach. The repetition of this process results in vibrations along the skin. These vibrations make up a soundwave. The conversion from light to soundwave was critical for this cutting-edge medical device as soundwaves travel deeper into the body allowing for a more in-depth image of the desired area.

After the conversion, the soundwave travels into the body and is reflected at varying frequencies as skin, muscle, and bone tissue absorb different amounts of the produced soundwave. The reflected soundwave is then absorbed by the second laser. Finally, the information received by the second laser is translated into an image. This medical device is profound by converting the light wave to a soundwave in order to remain independent from the body.

Although ultrasound is already considered a non-invasive procedure, the ability to conduct one without any contact at all is beneficial to patients who cannot be touched. Such patients could be infants, burn victims, and patients trapped in an accident. The researchers at MIT hope to improve the depth and accuracy of this new medical device. The researchers also hope to decrease the size of the technology with the aspiration of making the laser ultrasound a household medical device for preventative and proactive medical care. With technology like this already being discovered this early in 2020, it is clear that the future is bright, inventive, and upon us now!

To see an explanation of the laser ultrasound directly from MIT, please click here. For another article on this topic, please click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post The Future is Now: A Zero Contact Ultrasound appeared first on Focal Point.

As outlined on their website here, Health Canada is asking the following from Market Authorization Holders:

· To review their products and manufacturing processes for the possible presence of nitrosamines

· To take any necessary measures to ensure that their products do not contain nitrosamines at levels exceeding the accepted limit

· To test products if a risk of nitrosamines is identified

· To immediately report to Health Canada if nitrosamines are detected

More specifically, it is now recommended that all Market Authorization Holders “work with API and drug manufacturers to review their API and drug product manufacturing processes [and] conduct risk assessments, taking into account their knowledge of the manufacturing processes, potential sources of contamination and any other root causes of formation and presence of nitrosamine impurities”. As outlined in their question and answer document, Health Canada has stated that when a nitrosamine impurity is detected at any level during a risk assessment, you are to inform them immediately, as well as submit any available details of the risk assessment to them. In all other circumstances, risk assessment documentation should be retained by the Market Authorization Holder. However, it should be noted that Health Canada can request to review the MAH’s risk assessment report for any product and will request this information directly from the MAH, as necessary.

At the time, this information pertains only to “human pharmaceutical products containing chemically synthesized active pharmaceutical ingredients (APIs), including prescription and non-prescription (over the counter) drug products” as well as “chemically synthesized excipients and raw materials used in the manufacturing of drug products, and drug products that have been approved but are not yet marketed”. Therefore, products that fall under the classification of cosmetics or natural health products are not affected by these changes at this time.

Health Canada has stated that “Nitrosamines are not expected to cause harm when ingested at low levels. For example, a person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer. As the health risk is associated with long-term use of a contaminated drug, Health Canada continues to underscore that people who take prescription sartan, ranitidine and nizatidine drugs affected by this issue, including recalled ranitidine and sartan drugs, should continue taking their medication until they have obtained an alternative treatment from their health care provider. Not treating a condition may pose a greater health risk than

potential nitrosamine exposure.” If you are a patient concerned about these new changes or that your medication may be affected by these updates, Health Canada advises you to contact your health care provider for more information.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

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With regard to how the process of implementing these changes works, now that they have officially been adopted by the European Commission, the changes will be put forward to the European Parliament and Council of Ministers, who will have two months, or until December 4th, to object to the regulation changes. At this time, if no objections were raised, the changes will be published in the form of an official act and the new classifications will take effect 18 months later. That being said, the changes have already gathered a significant amount of controversy since being adopted by the European Commission. Two member states, the Czech Republic and Germany, have already presented objections, with several others advocating for an extension to the objection period deadline to allow for more time for other member states to voice concerns or comments on the changes, claiming that the regulation was adopted “despite a tide of opposition from industry worldwide, NGOs and some member states” according to another ChemicalWatch article on the issue.

While discussing these potential new classifications, it is important to take into consideration that titanium dioxide is safely used in a wide variety of personal care products, including creams, lotions, and colour cosmetics, as a sunscreen active and colourant, as it has proven to present a low risk of exposure during topical use. It is when titanium dioxide is in an inhalable form, such as a powder, that it begins to become hazardous, and is considered a possible carcinogen by the International Agency for Research on Cancer. For these reasons, the reclassification of titanium dioxide by the European Commission pertains specifically to the chemical when it is in a power form. The full annex from the European Commission with the list of reclassifications can be found here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

The post European Commission Adopts Major Changes to Titanium Dioxide Classification appeared first on Focal Point.

Microplastics are manufactured and used in many products on the European market. These ‘intentional’ uses of microplastics are the focus of the proposed restrictions. The potential posed environmental and human health risks of microplastics are that they are small (easily ingested), resistant to environmental biodegradation, and practically impossible to remove from environment. They are primarily released to the environment down the drain, through municipal solid waste, or through direct release.

The proposed restriction on microplastics is comprised of 3 measures (from ECHA Annex XV Restriction Report)

1. “a restriction on the placing on the market of microplastics on their own or in mixtures where their use will inevitably result in releases to the environment, irrespective of the conditions of use. For some of these uses, a transitional period is proposed to allow sufficient time for stakeholders to comply with the restriction.”
2. “a labelling requirement to minimise releases to the environment for uses of microplastics where they are not inevitably released to the environment but where residual releases could occur if they are not used or disposed of appropriately”
3. “a reporting requirement to improve the quality of information available to assess the potential for risks in the future.” (must report identity of the polymer(s) used, purpose and quantity used of the microplastic, and the quantity released to environment)

The proposed restriction is estimated to result in a reduction of approximately 400 thousand tonnes of microplastics emission over 20 years. With the third measure listed above, the ECHA has proposed a way to collect additional information on the uses for potential improvements in the future.

D4, D5, D6:

Octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) are cyclic volatile methyl siloxane (cVMS) substances with four, five, and six siloxane groups, respectively. They are manufactured and used in a variety of European sectors, especially for leave-in and wash-out cosmetic products. D4, D5, and D6 were found by the ECHA to have persistent, bioaccumulative and/or toxic properties, which give rise to concerns due to their potential to accumulate in the environment and cause unpredictable, irreversible long-term effects.

The proposed restriction to D4, D5, and D6 (from ECHA Annex XV Restriction Report) is that they shall not be placed on the market as substances, or as constituents of other substances at a concentration equal to or greater than 0.1%. This restriction shall come into force at least 5 years following the publication in the Official Journal for leave-on cosmetic products, and after at least 10 years for use of D5 in dry cleaning. For all other uses, the restriction will come into force 2 years after publication in the Official Journal. There are some exceptions to the restrictions on D4, D5, and D6 use for medical device purposes and for non-cosmetic use.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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