We have a history of more than 20 years collaborating and working directly with the U.S. FDA and the European Commission on matters relating to reporting and notification obligations, submission of new or modified product applications, and inspection and enforcement. We speak "regulatory-ese" and know how to navigate the complex regulatory maze. In addition, we have extensive experience writing complete, detailed and accurate regulatory submissions.
Chemular's regulatory services include:
Through our partners, we are able to provide a wide range of test and validation services to support your PMTA and TPD2 submissions and applications, including:
Click here for more information on our product testing and validation services.
The US FDA and the European Commission expect manufacturers to conduct and document an analysis of the risks associated with the use of their products, prior to placing the products on the market.
Chemular will assist you in developing a process for identifying, analyzing and prioritizing risks, followed by a concerted effort and commitment of resources to minimize, monitor, and control the probability and/or impact of hazardous situations or to maximize the realization of opportunities.
Chemular will prepare your risk assessment for submission to US FDA on a Substantial Equivalence Application or PreMarket Tobacco Application, describing the product and all the parameters, such as test results, the type(s) of consumers selected for injury scenario(s), and the probabilities with the underlying data and assumptions.
The resulting product risk profiles will become part of your product submissions and will be the primary mechanism for determining when to report suspected adverse effects to the FDA and Competent Authorities.
Click here to learn more about Risk Management.
A product is considered substantially equivalent when it has the same characteristics as a predicate tobacco product that has been approved by FDA or has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to regulate the product because the product does not raise different questions of public health.
Chemular will prepare and submit your Substantial Equivalence application using the FDA e-submitter, including:
Contact Us today to discuss how we can assist in your SE submission or manage it for you.
Minor modifications to currently marketed, approved tobacco products can be granted an exemption from Substantial Equivalence (SE) reporting requirements if the modifications are minor, such as adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive.
FDA must concur with your determination that the modification is minor and a SE Report is not required.
Chemular will prepare and submit your Request for an Exemption under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act through the FDA e-submitter application. The Exemption Request includes:
Contact Us today to discuss how we can assist SE Exemption Request or manage it for you.
The PreMarket Tobacco Application (PMTA) is an extremely complex, science-based compilation of documentation which completely describes a product and its impact on human health and safety, and requires input from subject matter experts and the corroboration of accredited laboratories and scientists. The application must be formatted and delivered to FDA according to an established specification and submitted through FDA’s e-submitter application on the internet. Operation of e-submitter requires specialized training.
Chemular will prepare your complete PMTA submission according to FDA Draft Guidance for Industry: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, and submit to FDA using the e-submitter on the FDA website.
The estimated time frame for the complete compilation of the PMTA, including the time needed for toxicological analyses, stability testing, emissions testing, etc. is 16-20 months.
We will compile multiple products on a single, combined cover letter to reduce cost, and utilize our vast library of publications, articles, and clinical study reports to mitigate clinical and non-clinical testing burdens.
Chemular will assist you in developing an accurate and concise application to comply with e-submitter criteria, write all elements of the entire PMTA submission, and perform the following:
Contact Us today to discuss how we can assist in your PMTA submission or manage it for you.
The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). The directive establishes:
The UK Tobacco and Related Products Regulations 2016 come into force on May 20, 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.
For most countries, the Product Notification must be submitted through the European Common Entry Gate (EU-CEG) notification portal.
Chemular will prepare the product notification, including:
We can handle your Product Notifications from start to finish, including product testing, or just handle the paperwork. Click here for more information on our product testing and validation services.