Achieving Success in National Scientific Advice Procedures

National Scientific Advice (NSA)

National Scientific Advice (NSA) is a provision of expert guidance and recommendations by relevant regulatory authorities and expert panels to assist applicants, such as pharmaceutical companies or medical device manufacturers in relation to the development, quality, and evaluation of medicines and medical devices. Scientific advice plays a crucial role in guiding the development, evaluation, and regulatory decision-making for medicines and medical devices.

NSA process typically involves interactions between the applicant and the regulatory authority or expert panels. The applicant submits specific questions or requests for advice, along with relevant data, study protocols, or other supporting information. The regulatory authority or expert panel reviews the information and provides their expert opinion, recommendations, or clarifications in response to the questions posed. These interactions may take the form of written advice or face-to-face meetings, depending on the complexity of the issues and the specific requirements.

Scope

NSA may cover questions related to the pharmaceutical quality (including biological and biotechnological aspects), the assessment of medical devices, the design and conduct of non-clinical investigations and clinical trials of medicinal products and medical devices (including biostatistics), as well as aspects related to pharmacovigilance and the risk management plan. Each National Competent Authority (NCA) may have an area of expertise in which they can provide NSA, while some of the questions would fall out of their scope. In general, NSA should not be viewed as a preliminary assessment of data in the light of a forthcoming Marketing Authorization Application (MAA) submission.

Timelines

The NSA can be requested at any stage of the initial development of a medicine, before submission of MAA and during the pre-submission period for a renewal or variation to an existing marketing authorization. Advice can be sought also in post-authorization phase.

It is important to remember that the timelines will vary greatly depending on the NCA chosen, type of question asked and the way in which the feedback will be given.

Feedback

NSA can be received as face-to-face or teleconference meetings with or without written answers, and as written responses. This depends on the NCA issuing the NSA, on the type of questions and special situations e.g., during the pandemic face-to-face meetings were replaced with teleconference meetings and/or written response.

Face-to-face meetings and teleconference meetings usually range from 1 to 2 hours, and the applicant is responsible for providing meeting minutes to the NCA.

The consultation is based on currently valid regulatory requirements and scientific knowledge. The scientific advice provided by NCA is not binding to either NCA nor the applicant for the purpose of medicinal product development and future marketing authorization applications.

Simultaneous National Scientific Advice (SNSA)

Simultaneous National Scientific Advice (SNSA) is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one NCA at the same time. The scope of SNSA includes regulatory or scientific questions related to quality, safety and efficacy of medicinal products. Questions can relate to products under development as well as authorized products. Queries related to Health Technology Assessment and reimbursement are currently excluded.

The EU Innovation Network (EU IN) has launched phase 2 of the SNSA pilot and it will run for a two-year period until the end of 2024. This phase of the SNSA pilot has a specific focus on scientific advice to facilitate clinical trials within Europe. NCAs that are currently participating in pilot phase 2: Austria, Belgium, Czechia, Croatia, Denmark, Finland, France, Germany, Spain, Hungary, Ireland,  Italy (only as an observer), Netherlands, Norway, Poland, Portugal, Sweden. This list is subject to change.

Each SNSA will involve two participating NCAs with the possibility of a third NCA joining as an observer. In justified cases, the involvement of additional MSs in a single SNSA procedure could be considered. Participation of an NCA in any individual SNSA procedure is on a voluntary opt-in basis.

Achieving Success in National Scientific Advice Procedures

In navigating the complex landscape of National Scientific Advice, it’s clear that having a seasoned guide can make all the difference. That’s where we come in. As subject matter experts with extensive experience in the intricacies of regulatory processes and scientific evaluation, we’re here to help you every step of the way. Whether you’re at the initial stages of development or navigating post-authorization phases, our team is equipped to provide the strategic guidance and support you need.

If you’re seeking expert advice to ensure the success of your pharmaceutical or medical device projects, don’t hesitate to reach out. We’re here to turn your regulatory challenges into opportunities for success. Contact us today to learn how we can assist you in achieving your goals with confidence.