Competitive Generic Therapies (CGTs) are designations for products that have inadequate generic competition in the market due to low market potential, less profit margin, or complexity in manufacturing. Inadequate competition, as defined by the FDA, means that there is not more than one approved drug in the active section of the orange book.
Proprietary and confidential information about the facilities and processes used in the manufacturing, processing, packaging, and excipients are included in a Drug Master File (DMF) and submitted to the United States Food and Drug Administration (US FDA) in support of the applications and other DMFs. A DMF submission is not mandatory.
Due diligence assessment involves a detailed review of the existing data, Regulatory strategy, and study plans for the generic drug product per the Health Authority (HA) requirements. Following a proper process can help minimize future risks or hurdles, from the drug development stage to the Abbreviated New Drug Application (ANDA) approval.
Changes with the potential to impact Module 3 of the CTD require careful and thorough assessment to determine the appropriate course of action. The change control evaluation of MAA must include a full understanding of the change, visibility of all impacted products (i.e., finished products and APIs), and must determine all countries where those products are registered. This might also include countries where a new product submission or approval is pending.
Whether an application is required for a new generic product application, or post-approval life-cycle maintenance, conducting thorough MAA submissions gap analysis and accurate authoring can be crucial when preparing any application. They help to minimize avoidable delays, reduce the risks of rejection and are thus important in leading to health authority approvals. A gap analysis review of submission documentation against the relevant European guidelines a
Health Authority interactions in Europe help in drug product approvals and can have a positive impact on the approval timelines and overall costs. This can include Regulatory agency interactions with the European Medicines Agency (EMA) and other regional Health Authorities (HAs) for EU and non-EU countries).
Post-approval changes to drug substances can arise throughout the lifecycle of a drug product and must be addressed appropriately. After the approval and during its commercialization, manufacturers may propose certain changes to a product and/or the active substance for optimizing operational costs, increasing productivity, administrative reasons, etc.
MAA publishing and submission is a critical step in the entire generic drug approval process as it includes all documents and information submitted to the Regulatory agency for review. Generic MAA submissions must be made in accordance with the standard Regulatory procedures and formats as recommended by the EMA.
Active Substance Master Files (ASMFs) contain detailed information on the manufacture and properties of active substances and are, therefore, valuable and confidential. The ASMF ensures the protection of the manufacturer’s intellectual property and allows applicants and Marketing Authorization Holders (MAHs) to undertake responsibility for the medicinal product and the quality of the active substance.
Health Canada can send requests like Screening Deficiency, Clarifax and Notice of Non-compliance to the applicants for additional information/clarification on the content that has been submitted in the ANDS/DIN Application/MF, so that the technical review shall be completed and approval shall be provided.
It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.
An Innovative Pharmaceutical Company
This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.
USA-based Pharmaceutical company
The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!
Research and Technology based US pharmaceutical company
Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.
US based leading biopharmaceutical company
We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.
A Privately Held Pharmaceutical Research and Development Company
Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.
UK multinational pharmaceutical company
Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.
Canada based, global pharmaceutical company
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