Abbreviated New Drug Submission
A request for approval from Health Canada for a generic drug. Allowing manufacturing and marketing to move forward, it essentially submits efficacy and safety data for review.
How Abbreviated New Drug Submission (ANDS) Work
Generic drug makers provide low-cost alternatives to expensive brand-name drugs. First, they get approval to manufacture and distribute these products. Pharmaceutical companies have to file an ANDS, or an Abbreviated New Drug Submission, with Health Canada. They are the federal administrator of the country's health matters.
The term abbreviated is used in the title because the submission doesn’t require clinical or pre-clinical data, similar to filing an Abbreviated New Drug Application or ANDA in the US. Instead of tests on animals or humans, it relies on establishing bioequivalence between the generic and the innovator drug.
An ANDS is in contrast to an NDS or New Drug Submission where brand name drugs seek approval, and during which they undergo rigorous and time consuming clinical testing processes. So the ANDS contains the new drug's unique marketing name, its dosage form, strength, and marketing approvals for the US, the EU, Australia, Singapore, and Switzerland, if any.
Example of an Abbreviated New Drug Submission (ANDS)
Let's say that the LiveClear company wants to distribute their generic version of Acetaminophen, which they're calling "Clearynol." To obtain manufacture and marketing approval for Clearynol in Canada, LiveClear must file an Abbreviated New Drug Submission or ANDS.
They'll need to include data comparing Clearynol's bioavailability with that of the brand name drug on this application. Bioavailability means how much time it takes to be available in the bloodstream, a key factor for comparing biological equivalence. These comparisons take several factors into consideration:
- Dosage form
- Route or style of administration
- Intended use
- Manufacturing quality
They'll supply data regarding comparison studies for efficacy and safety between the Clearynol drug and the original brand name drug, referred to in the ANDS as the reference drug. For proposed drugs with delivery devices, this submission states data from operational and physical characteristics of both the brand name and the generic drug’s devices.
Significance of an Abbreviated New Drug Submission (ANDS)
Investors have a vehicle to evaluate their future biotechnology prospects of profitability by examining their ANDS pipeline. This Canadian process for new generic drug marketing approval has similar technical connotations with that of the FDA in the US and the European EMA or Medicines Agency.
With an ANDS, drugs that have already received approval in the US or with the EU health regulators have a more straightforward registration process in Canada. Aside from data on bioequivalence comparisons between the innovator and generic counterparts, Health Canada doesn't delve into clinical trials, ingredients, manufacturing controls, or reactions as it would for a New Drug Submission or NDS.
The generic drugmaker submits mock-ups of labels to be used on the packaging as well as statements of contra-indication, allergic reactions, or side effects to be expected. After approval is granted, the generic drugmaker is held to the same obligations and duties as the innovator for updating labeling and monitoring safety.
Types of an Abbreviated New Drug Submission (ANDS)
Health Canada regulates the process of approving innovator or brand name drugs and those manufactured by generic drug makers. Under the Food and Drugs Act, with guidance through the Food and Drugs Regulations, the health regulator issue's a Notice of Compliance or NOC after uniquely identifying the drug using a DIN or Drug Identification Number.
After filing an ANDS, the process can take anywhere between 6 months and two years as health Canada reviews efficacy and safety information, comparing the generic against the brand name drug. The drug continues to be monitored even after approval is granted, meaning it's been found to meet the F&D Regulations standards for human use.
Yes, this process may appear intimidating and complex. But it’s effective and works if an ANDS follows proper guidelines and has the correct documentation for data on trials and other research. By anticipating the health regulators' potential concerns, such as information reporting on contra-indications and adverse drug reactions, pharma applicants can smooth the generic registration process.
History of Abbreviated New Drug Submission (ANDS)
New generic drugs get manufacturing and marketing approval in Canada after submitting an Abbreviated New Drug Submission or ANDS. Health Canada tests for the new drug's bioequivalence with the branded drug, a degree of bioavailability likeness that's unlikely to cause therapeutic effects differences.
Generic pharmaceutical s manufacturers must also make sure that the innovator's Certificate of Supplementary Protection (CSP) has or is about to expire before filing an ANDS. CSPs in Canada last two years as opposed to five in the US, and a generic drug's non-clinical information on the ANDS can be omitted as it isn't relevant.
If the generic drugmaker uses new ingredients that aren't listed on the DSL or Domestic Substances List, the manufacturer must submit a New Substances Notification package to environment Canada. An ANDS also contains tests for bacterial endotoxins in sterile drugs, and the applicant pays a fee alongside the submission.
Abbreviated New Drug Submission (ANDS) vs. New Drug Submission (NDS)
While the ANDS represents generic drug applications for marketing approval, the same is done for new innovator drugs with a New Drug Submission or NDS. Before entering the Canadian market, every new medicine must have its NDS approved, a similar fact that applies to generic drugs and their ANDSs.
Unlike an ANDS, an NDS is conclusive. It rigorously establishing data that includes all the information related to the new drug, its ingredients, and the results of pre-clinical and clinical trials. An NDS sets out the entire manufacturing process, stating if the drug has any reactions on humans and can be used to file for changes in dosage, labeling, new indications, or packaging.
Both NDS and ANDS applications are made after the review process is completed to be issued with a NOC or Notice of Compliance certification. Health Canada uses the Management of Drugs Submission Policy to review the applications, and companies can buy other firm's submissions to upgrade their pipeline for investor appeal.