This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

• Adequacy of characterization and function of the nanomaterial
• Complexity of the nanomaterial structure
• Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
• Predictability of in vivo release based on in vitro methods
• Physical and chemical stability
• Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

If you need any assistance or have any questions about whether this applies to your company or have any concerns, do not hesitate to contact us.

The post Final FDA Guidance for Drugs & Biologics Containing Nanomaterials appeared first on Focal Point.

As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

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The state government aims to have this act become effective July 1, 2022. However, it should be noted that this bill has only passed the first reading in the house (on April 13, 2021). Since then, there has been no update. The bill must still undergo Referral to Committee and its Second and Third Readings prior to approval.

Since this bill has only passed the initial reading, there is no action needed as yet. However, once this act becomes effective, your company will be required to update your website if selling cosmetic products in North Carolina.

If you have any questions on this, please do not hesitate to contact us.

The post New Legislation for North Carolina appeared first on Focal Point.

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

• Monograph Drug Facility (MDF) Facility Fee – USD 24,127
• Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

• Tier 1 Monograph Fee – USD 507,021
• Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.

The post FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2022 appeared first on Focal Point.

• Effective Dec. 31, 2021, you must cease all production of alcohol-based hand sanitizers.
• If you cease production of alcohol-based hand sanitizers, you must deregister.
• The deadline to sell any alcohol-based hand sanitizer produced on or before Dec. 31, 2021 is Mar. 31, 2022.
• If you wish to continue production, you may do so provided you comply with the OTC topical antiseptics tentative final monograph and other requirements, including FDA cGMP.

If you would like further information on this, please do not hesitate to contact us.

The post FDA Withdrawal of Temporary Guidances for Alcohol-Based Hand Sanitizers appeared first on Focal Point.

The FDA will provide companies with guidance on limitations and warnings needed when certain ingredients are incorporated in a product. Other powers brought forth by this bill includes authority over recall. If a company refuses to conduct a recall, the FDA will have the authority to issue recalls on any product that is likely to cause significant harm. 

Other highlights :

• Registration with the FDA, disclosure of ingredients and attest to safety records 

• Must report adverse events within 15 days and annual reporting of all reported adverse health events

• banning of products that intentionally contain the harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substances).

• Issuing regulations that will outline GMP for personal care products 

• Flexibility for small businesses 

• Website only business models will be required to provide full labeling including ingredients and warnings

• Authority to seize counterfeit products and seek civil penalties for any violations 

• State safety laws in effect prior to the date of enactment will remain in effect

• To collect user fees from manufacturers to help fund oversight activities

• This bill is being supported by many companies and associations

For more information on this article and to understand how this may affect your business’ day-to-day activities and future pipeline planning, please contact us

The post Senators Introduce Bill – Modernizing the Safety of Personal Care Products appeared first on Focal Point.

Does this apply to your company?

The facility fee for 2021 applies to any foreign or domestic facility engaged in manufacturing or processing a finished dosage form of an OTC monograph drug to be sold in the USA during the period between January 2020 and December 2020. This includes all facilities that perform the following business operations: finished dosage form manufacture, label, manufacture, pack, relabel, or repack. It also applies to submitters of an OTC Monograph Order Request (OMOR), except for those which request certain safety-related changes with respect to an OTC monograph drug. If your facility is solely manufacturing OTC hand sanitizer products, such a facility is not subject to the OTC Monograph Drug user fee program facility fee.

How much do you owe and when?

If you are an OTC monograph drug facility (MDF) – USD 20,322

If you are a contract manufacturing organization (CMO) – USD 13,548

If you submit a Tier 1 OMOR – USD 500,000

If you submit a Tier 2 OMOR – USD 100,000

Note: The above fees are for the period from Oct. 1, 2020 through Sep. 30, 2021.

Payment is due no later than May 10, 2021.

If you need assistance with determining whether the FDA OTC Monograph Drug user fee program applies to your company or you have any questions relating to payment options, please do not hesitate to contact us.

The post FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021 appeared first on Focal Point.

The REP information will be sent to the HPFB via the Common Electronic Submissions Gateway (CESG) – similar to FDA drug submissions. XML format will be used and is ideal for Health Canada as it will minimize errors and therefore will improve consistency and reliability of the information captured. This new approach also eliminates the need for media such as CDs and DVDs. The template for the REP will aid in easier and faster data entry with drop down lists and predictive text.

Through the REP template, HPFB will collect routing IDs that will be used for two-way secure communication which will allow for quicker communication. The steps to beginning this process can be found here. As well, information on obtaining a dossier ID or obtaining a dossier from non-eCTD to eCTD is available here. It should be noted that the dossier is considered the REP dossier upon receipt of first transaction including a REP Regulatory Transaction XML file, afterwards the REP dossier must be provided using the REP company template. Health Canada recommends the familiarization of the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use and beginning the process of registering and setting up a CESG account and obtaining a dossier identifier as soon as possible, as this may take some time.

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 Health Canada: Mandatory Use of New Regulatory Enrolment Process for Drug Submissions appeared first on Focal Point.

However, both small beauty brands and multinational cosmetic corporations are rethinking their packaging models to consider more eco-friendly options in order to reduce their environmental footprints. A post published by Cosmetics Design USA states that Veolia, a world leader in waste management, is teaming up with Unilever to take a leadership stance in defining responsible packaging initiatives for future generations. Recyclables are only recycled if they are deemed as useful materials for future use. Thus, Unilever not only aims to use plastic packaging that is made of fully recyclable materials, but to incorporate 25% of recycled material into its packaging by 2025. Unilever and Veolia plan to start their collaboration by collecting materials from India and Indonesia.

The Terracycle Zero Waste Box

Although the spotlight is on eco-friendly cosmetic packaging, these changes can’t happen overnight. According to Cosmetics Design USA, TerraCycle has taken a different approach towards diverting from filling landfills with post-consumer waste. RecycleSmart has teamed up with Terracycle to introduce waste collection boxes, called the Terracycle Zero Waste Box, designed to recycle anything.

How does it work? A customer will first select a waste stream that they would like to recycle. The waste streams span a large variety of household items such as jewellery, luggage bags, garden products, and health care packaging. Once the waste stream is chosen online, the boxes can be ordered and delivered to the customer’s house to be filled up. Once the boxes are full, the customer ships them back to Terracycle, where the product constituents are sorted into metals, plastics, organics, fibers, fabrics, glass, e-waste, cigarette waste, and latex paints. Once sorted, the products are repurposed into creative products instead of being sent to landfill.

It is evident that many companies are developing various approaches to tackle the environmental issues that threaten society, and consumers these days are expecting no less.

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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A Health Canada project worked to reduce this burden by decreasing the regulatory requirements for sunscreen products being imported from the U.S. After the one-year pilot project, which ran from February 27^th, 2017 to February 27^th, 2018, Health Canada is now looking to expand the pilot to include additional jurisdictions, including Mexico, Japan, Australia, Switzerland, the European Community (EC), and the European Economic Area – European Free Trade Association (EEA – EFTA). This project, to expand the Sunscreen Pilot to include other countries with existing Mutual Recognition Agreements (MRAs) will significantly reduce, or eliminate completely, the need for additional confirmatory testing that is done when importing sunscreen products into Canada.

The details of the expansion are outlined in Drug Establishment Licensing (DEL) Bulletin #41, which was issued by Health Canada in November 2018, and will come into effect February 14^th, 2019. The Expanded Pilot replaces the 5-year limit on absence of US Food and Drug Administration or Heath Canada inspections with mandating that GMP renewal evidence be submitted on or before a New Evidence Required By (NERBY) date. It also includes sunscreen products which have been fabricated in Canada, but packaged, tested, or labelled in any of the original or newly included jurisdictions. Currently, the project’s focus is on sunscreens, however other low-risk products such as anti-dandruff shampoo and mouthwash may be introduced in the future.

The application process for participating in the Expanded Sunscreen Pilot includes submitting a complete application package, which can be found on the Health Canada website.

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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