Submissions

ERA recognises that a regulatory submission is a means to an end, and not an end in itself. The aim is a successful marketing authorisation, and this requires efficient and appropriate responses to agency questions and objections. Our team is often called in to help at this crucial stage of the review process, providing input on the interpretation of questions, understanding the additional documentation that will be required and the way it needs to be presented in a response package.

The US and European regulatory procedures for biopharmaceutical products differ significantly with respect to responding to questions and objections on the part of the assessors. In the US, where the review already starts at the IND stage, and proceeds through the BLA, the process is somewhat iterative. By contrast, in the EU, the Centralised Procedure for biotech products offers just one main opportunity for a company to satisfy questions from the CHMP. In order to provide a satisfactory response package as the absolute prerequisite for a subsequent marketing authorisation, the company must first understand the questions, the additional data that may be requested, the level of detail that is required, and the manner in which this needs to be presented.

ERA has considerable experience in the interpretation of consolidated lists of questions and objections, which should be analysed by a company in the light of the assessment reports that are provided by the rapporteur and co-rapporteur. It also needs to be appreciated that the time available to the assessors to review the company’s response package is limited. Hence, in order to achieve success, the responses must be compiled in a way that affords efficient review by the regulator.

This requires clarity in the approach and a clear presentation of the data, in order to satisfy the objection, as well as justifying the company’s position on the issue. Here, ERA’s expertise can be invaluable.