Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

European centralised procedure

BioVentures Consulting Limited has significant experience in European Centralized Procedures. We can advise whether or not it is mandatory for products to follow the centralized procedure. BioVentures Consulting Limited can advise on the implications of the centralized procedure (e.g. option for conditional approval, exceptional circumstances or accelerated review; the interactions and communication channels with EMA; the transparency of information in the public domain, and the timelines involved).

A poor understanding of the procedures can lead to delays

BioVentures Consulting Limited can also provide consultancy advise on the potential opportunities of filing via the centralized procedure and the factors affecting the assessment outcome. We can ensure that the optimal development plan has been followed and is in accordance with the regulatory guidelines, EU Scientific Advice and that the data submitted is robust. BioVentures Consulting Limited can work with clients to compile well-organised, clear documentation, which supports all claims in the SmPC. We would also advocate that issues with the development plan and data are appropriately addressed in the file.

It is important to understand and manage all steps of the centralized procedure. A poor understanding of the procedures can lead to delays. BioVentures Consulting Limited understands the importance of pre-filing activities, from the planning of the filing date (around timetabled monthly submission dates), to agency meetings (including pre-rapporteur assignment), procedure eligibility request, letter of intent and the request for rapporteur assignment (7-months pre-filing), the EMA pre-submission meeting and the rapporteur pre-submission meeting (including a preliminary reaction to the data and proposed SmPC), submission of proposed brand names and the PIP compliance check.

It is also important to understand the filing considerations. Here the expertise of BioVentures Consulting Limited can be invaluable. For example, the need to communicate changes in anticipated submission dates to the EMA and rapporteurs (they have resource implications too!), careful management of the administrative elements (Part1A) for the submission, and the post-submission liaison with the EMA necessary to ensure smooth validation.

Day 181 Oral explanation... this is a team effort, and involves robust preparation

Importantly, BioVentures Consulting Limited can partner with client and use the Day 80 Assessment Reports to begin to draft the responses. It is easy to under estimate the number of questions! BioVentures Consulting Limited can help with resource planning in addressing the List of Questions (LoQs). We can help interpret the questions to ensure a clear understanding of what is required and have the scientific expertise to address the technical questions directly (indeed this is a core competence of the BioVentures Consulting Limited service). Likewise, we can also provide expert assistance with the Day 121 LoQ responses, and the written responses following the Day 150 Joint AR. If necessary we can help companies prepare for the Day 181 Oral Explanation (this is a team effort, and involves robust preparation) and with responding to questions of the Scientific Advisory Group if convened by the CHMP. BioVentures Consulting Limited can then assist with the preparation of provisional post-licensing measures.

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