Literature based registration submissions (LBS) an opportunity for your company?

Have you considered using a Literature Based submission (LBS) to extend the registration conditions of an existing product, change the Product Information details or even register a new medicine?

The team at Mister Wolf Consulting (MWC) has extensive experience in developing and preparing LBS applications.  Our experience covers the provision of assistance to evaluate the feasibility of an LBS through to the preparation of complex applications requiring the necessary Module 1, 2, 4 and 5 common technical documentation and related Product Information, Consumer Medicine Information and Risk Management Plan.

Literature based submissions (LBS) can provide an effective pathway to register new medicines or vary the registration conditions of existing medicines when a sponsor does not have access to specific in-house safety and efficacy data.

If certain conditions are met, the safety and efficacy of the medicine in the proposed indication can be supported by published literature identified by a systematic search following discussion and agreement with the TGA.

Although the TGA considers an LBS on a case-by-case basis, our experience has found that medicines which have been marketed in other countries with similar regulatory standards for over 10 years, and which are supported by good quality controlled clinical trials are good candidates for this approach.

An LBS can include both in house and published data (Hybrid Application) and may be used to support both prescription and higher risk over the counter medicines. An appropriately developed search strategy can also identify data relevant to support the required performance and safety elements for your medical device Clinical Evaluation Report (CER).

Depending on the available evidence, an LBS may also require the inclusion of published nonclinical data, particularly if current information lacks specific details regarding safety issues which cannot be adequately addressed by clinical data such as genotoxicity, reproductive toxicity and carcinogenicity.

In our experience, the extent of nonclinical data required to support an LBS is determined by a range of factors including indications for use, target population and pharmacological characteristics. Each application is different and needs individual considerations.

MWC has over 10 years’ experience in preparing material supporting LBS, including applications for first in world registration approvals.

If you think MWC can help, contact us.