Scientific Advice Meetings – Advice for Companies

Scientific Advice Meetings are an area where clients and prospective clients consistently seek our support.  Our expert team has significant experience of dealing with relevant agencies for such meetings.  This article looks at a number of issues related to the meetings including the growth in the number of meetings being held annually and what your company can do to prepare for a Scientific Advice Meeting. In the current regulatory climate, there have been significant increases in regulatory requirements and assessment levels of Marketing Authorisation Applications (MAA). This, in turn, has led to an increased requirement for applicants to request scientific advice from the relevant agencies for support in advance of submissions.  Scientific Advice (SA) services are offered across many of the competent authorities on a national level and also by the EMA and EDQM, where required. Meetings can also be requested with a combination of two or more agencies and examples may include combining a meeting with the EMA and FDA or the HTA (Health Technology assessment) etc.

Growth in Number of Meetings

The EMA has reported an increase from approximately 70 scientific advice meetings in 2001 to approximately 600 meetings in 2016 and has stated that obtaining and complying with scientific advice is strongly associated with a positive outcome of a Marketing Authorisation Application, with almost 90% of those who obtain and follow the advice receiving a positive opinion compared to 40% for those who do not follow the advice. The SA meetings are data-driven and based on scientific knowledge. All information shared is strictly confidential. However, it must be noted that although the meeting does not represent a pre-approval of the dossier and the advice received is not legally binding, it is highly recommended that the applicant follows the advice or provides a suitable scientific and data-driven justification for deviating from the advice received.

Pre-Submission Meeting

Prior to the scientific advice meeting, the applicant can request a pre-submission meeting with the relevant agency, this meeting can be very beneficial and should be used to gauge how the questions are being received by the assessor/s. It can give the applicant foresight on the experts’ opinions of the topics to be discussed and is an opportunity to establish a personal contact in the agency. For applicants outside the EEA, it is recommended to nominate a contact point within the EEA for communication between the applicant and the agency. The advice can be given in writing, via teleconference or via a face to face meeting, the type of meeting will be arranged in advance with the agency.  It is advisable to seek the advice meeting before the submission of the MAA in relation to queries that have arisen for the applicant at the initial development stage of a medicinal product, the answers to these queries may not be covered by current guidance. The advice can also be sought post authorisation, where deemed necessary by the applicant. Examples for post authorisation queries include but are not limited to the addition of new pharmaceutical forms, the extension of the indication or significant changes in the manufacturing process. A briefing document detailing the background of the application and the reasons for the meeting request will be prepared and sent in advance to the agency. This document should clearly list the questions to be addressed at the meeting and detail the applicants’ position on each question with a well-defined justification for their position. The method of submission of the package and the fees payable to the agencies varies and should be verified by the applicant prior to requesting the scientific advice service to ensure the correct procedure is followed.

Timing of the Scientific Advice Meeting

In our experience the timing of scientific advice is crucial and it is vital that the right questions are asked during the meeting. The earlier in a procedure the advice is sought the more beneficial. Preparation for the meeting is key, all stakeholders must be chosen based on their experience in the relevant areas and each expert should be assigned responsibility for responses and discussions on their area of expertise. The questions should be concise and direct, the use of ‘open’ questions is not recommended. The meeting structure and agenda should be agreed in advance with the agency and this should be adhered to, where possible. It is essential that concise minutes are recorded and signed copies must be provided to the agency within the recommended time frame. The scientific advice reflects the standards that will be applied by the assessors during the MAA assessment and therefore, to aid approval, all advice should be taken on board in the application or a justification prepared to explain any deviation from the advice. If you would like us to assist you in preparing for a Scientific Advice Meeting then please do get in touch by completing the form below or calling us on 00353 52 61 76 706. [ninja_form id=1]

Further Reading from Acorn Regulatory

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Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s) Read the article here.

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• what to do when documentation is missing
• how to handle GMP variations
• what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

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KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  We look at its ‘3 pillars’ and what it aims to be.  Importantly, we look at how the FDA believes it will change how drugs are assessed in the United States of America. Read more about KASA here.