Proposed fees for veterinary drugs master files – Consultation comments
The Health Products and Food Branch (HPFB) is updating master file (MF) registration as a part of the continuing effort to implement a common intake approach for all drug product lines, including veterinary drugs. MF holders and applicants using MFs to support veterinary drug submissions will need to submit MF transactions via the Common Electronic Submission Gateway (CESG) using an application form in XML (Extensible Markup Language) format. This update is consistent with the transition of human drug MF application form to a web-based form effective June 26, 2023.
Additionally, fees will now be charged for MFs for veterinary drugs, to align them with the existing MF fee structure for human drugs. A public stakeholder consultation was held from June 2 – August 12, 2023. Comments received may be viewed below.
Both changes for veterinary drugs go into effect on January 2, 2024.
Four comments were received during the consultation period. These are listed in Table 1 below. Please note that comments are posted in the official language in which they were received.
Flavine North America, Inc.
As a 26 year veteran of the veterinary pharmaceutical API industry, I would like to comment on the proposal to implement fees for veterinary MFs. As an agent and distributor for various small to medium sized API manufacturers, Flavine North America, Inc. has faced this same question in the USA. As you are probably aware, we do not have MF fees for veterinary drug APIs in the USA. Flavine supports a good many veterinary drug product companies with APIs for both companion animals and food animals. Our primary clients are generic companies rather than pioneer companies.
Unfortunately, many of the products for animals have rather limited sized markets and generic companies can consider the potential return on investment too limited to invest in a drug registration. The drug product sponsor will likely be expected to cover the cost of the API MF fees, which only adds to the overall cost of development. This compounds the issue and leaves certain products without competition and pet parents and farmers with only the high cost pioneer drug. Alternatively, should a product be attractive for a drug product company to consider for generic development and approval, the share of the business for the API manufacturer is typically a small percentage. Should the drug sponsor be unwilling to pay the MF fee as well as the API producer, there will be lesser or perhaps no API options given the small API business opportunity resulting in no generic approvals.
In general, I would expect that with a MF program in place for veterinary APIs, API companies may rather focus development and regulatory resources on the more profitable human drug market. In my role in the AH segment of the pharma market, we are always faced with API companies rationalizing product development / R&D resources. There are many more larger and more lucrative products in the human health drug market and we struggle to get API companies that primarily support the human drug market to allocate resources for smaller veterinary new product development. MFs fees will only make the veterinary market less attractive.
I would like to provide a few comments related to the proposed updates to the fee structure to align with human drugs.
Member of the Public
I am concerned that, by adding a fee for filing veterinary drugs, that veterinary care may become more expensive. Already, pet parents can not afford the care they need for their loved ones. Please do not make veterinary care, which is in shortage, more expensive. Please also phase out the animal laboratory testing of veterinary drugs by the end of the decade. There are cruelty free ways to test medicines.
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