Continuing from last week’s post, the next step would be the regulatory submission process, which can fluctuate based upon the commercial and regulatory filing strategy. When submitting to the Food and Drug Administration (FDA) or European Medicines Agency (EMA), names can be submitted to the regulatory bodies as early as the end of a Phase II clinical trial, and as late as four months prior to the submission of a Marketing Authorization Applications (MAA) to the EMA. If the filing is with the FDA only, a later submission of the name, with a backup, can occur simultaneously with a New Drug Application (NDA).
The request forms for a review of a proprietary (invented) name can be seen here:
- FDA Form 1571 for IND submission
- FDA Form 356h for NDA/ANDA/BLA submission
- EMA Invented Name Request Form
If submitting to Health Canada, or to China’s National Medical Product Association (NMPA), or Japan’s Pharmaceutical & Medical Device Agency (PMDA) a Proprietary Name Review can be requested when applying for a new drug submission. It should be noted that whichever submission filing strategy a sponsor/manufacturer decides to take, there are strategic decisions that can be taken to ensure global consistency for a pharmaceutical brand.
Now, in terms of timing, the regulatory submission process varies depending upon the agency, but if requesting a brand name review through the FDA an approval for a drug name can occur within six months for companies filing pre-NDA, or as quick as three months for companies filing with an NDA.
Currently the EMA — specifically, the Naming Review Group (NRG) — is running a pilot program where the number of annual meetings to review invented names has been reduced from six to four meetings annually. This means greater likelihood that a sponsor/manufacturer requests for review of an invented name could be included at the next upcoming meeting. If the deadline is met via the ‘first come, first served’ basis, then the NRG will conduct its review and correspondence with the sponsor/manufacturer within the average timeframe of two to four months.
As for Health Canada, the length of time to review invented brand name assessments is dependent on the quality of the review packages that sponsors provide to Health Canada at the initial time of filing. Assuming the quality meets expectations, a brand name assessment can be conducted and approved in about three months of the submission being accepted into review.
Lastly, China and Japan’s level of predictability in brand name approval is still difficult to gauge at this moment, but conservatively speaking the approval of a brand name can takes upward of sixteen months to complete.
So, in summary, when looking to understand the length of time required to go through the pharmaceutical brand name development process, the answer is always, “it depends.” The most conservative answer for a global brand name would be to begin the process about two to three years prior to the submission of an NDA, NDS, or MAA to the regulatory bodies. Said differently, one could begin the brand naming process as early Phase 2 clinical trials and feel confident that attaining a legally viable name that meets all regulatory hurdles is well within the bounds of reality.