SAFETY PULSE VOL. 2

Posted February 15, 2018
SafetyPulse

When pharmaceutical companies are challenged with the task of identifying a short list of brand name candidates for a new compound, how soon should your brand name search and associated research start? How is the process begun? What is the earliest time a sponsor can submit a brand name for Agency review? How long does the brand name review period last?
Our newsletter, Safety Pulse™, answers these and many other questions in areas such as marketing, regulatory requirements, and trademark initiatives.
General questions regarding proprietary or nonproprietary name review or specific questions regarding a proposed proprietary or nonproprietary name for your compound can be sent to info@safemarkconsulting.com.

REGULATORY HIGHLIGHTS

In this section, we consider frequently asked questions from our clients and post our answers:

Q: We recently submitted our nonproprietary names to be considered at the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances to be held on 1-4 May 2018. What are next steps in waiting for a response?

A: Our answer can be found in the procedure outlined in the Guidance on the use of INNs for pharmaceutical substances (2017). Upon receipt of an INN request form, the WHO Secretariat examines the suggested names for conformity with the general rules, similarities with published INNs, and potential conflicts with existing names including published INN and trademarks.

A note summarizing the result of these checks is added to the original request which is subsequently forwarded to the INN experts for comments. Once all experts agree upon one name, the applicant is informed of the selected name.
Newly selected, proposed INNs are then published in WHO Drug Information with a deadline for a 4-month objection period. This period allows for comments and/or objections to be raised for the published names. The reasons for any objection must be clearly stated and will be evaluated by the experts for further action. Sponsors are asked to refrain from using the proposed name until it becomes a recommended INN in order to avoid confusion should the name be modified.

Two lists of proposed INNs are published yearly.

The final stage of the selection process is the recommended INN. It will serve to identify the active pharmaceutical substance during its life-time worldwide. Since the name is available in the public domain, it may be used freely.

Two lists of recommended INNs are published yearly.

Q. What is the most recent published proposed INN list?

A. The most recent INN proposed list was published on 19 January 2018. Congratulations to the sponsors of INNs found on this list!

Q. What is the average range (in months) for a USAN and INN name to be submitted, reviewed, approved, published twice, and ultimately used by the sponsor?

A. To be conservative, an average of 20-32 months should be calculated in your regulatory timeline for a USAN and INN name. Specific endpoints include:

  • USAN review is a rolling submission process and review takes 2-3-months on average.
  • Submission to INN will be at least 3 months before the consultation meeting held in either Spring or Fall.
  • Lately, we have seen an average of 14-16 months from INN consultation until a recommended INN is published (no issues or objections). We suggest an additional 6 months to accommodate a delayed review or publication.

HAVE YOU HEARD?

February 2018 marks the second anniversary for SafeMark Regulatory Consulting. We are extremely grateful to our partners-including advertising, branding, and creative agencies as well as pharmaceutical industry clients for making SafeMark’s 2nd Anniversary possible! In the last 2 years, we evaluated a total of 747 proposed names in the following types of projects:

Brand Name: 548

Brand/Modifier Name: 16

Generic/Nonprop Naming: 158

Library Name Bank Names: 25

We were given the opportunity to help our clients by offering these services:
• Name Safety Testing – Power of 3 Methodology
• Regulatory Submission Reports
• Failure Modes & Effects Analysis on portfolio naming strategies
• Labeling Research Study
• Nonproprietary Name – Risk Assessment and Response Letter(s)
• Rebuttal or Reconsideration Documents (In response to an Agency Rejection)
• Library Name Bank – Risk Assessment

 

About Brandsymbol

With over two decades of experience, brandsymbol was founded with the goal of revitalizing the agency-client relationship by innovating and transforming the branding process, to deliver world-class solutions, customized for each client. Our proprietary i4 Methodology is engineered to provide senior-level expertise, global creative, advanced legal & regulatory solutions to deliver clients world-class brands that are based on facts and figures, not opinions and observations.

About SafeMark

SafeMark is redefining the safety industry by implementing a new gold standard in name safety testing. Our primary objective is to provide healthcare clients with a simple and sequential approach to name safety testing that adheres to guidelines set forth by global governmental authorities.

For More Information:

Casey Peebles

cpeebles@brandsymbol.com

704.879.2503

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