Scientific Advice

Scientific advice is a provision of expert guidance and recommendations in relation to the development, quality, and evaluation of medicines and medical devices. It involves seeking input from regulatory bodies or expert panels to obtain scientific and technical expertise to support decision-making processes.

Within the European Union (EU) context, scientific advice is provided by relevant regulatory authorities and expert panels to assist applicants, such as pharmaceutical companies or medical device manufacturers, in navigating the regulatory requirements and ensuring the safety, efficacy, and quality of their products.

For medicines, the European Medicines Agency (EMA) plays a central role in providing scientific advice. The EMA advises on various aspects of medicine development and evaluation, including guidance on the appropriate tests, studies, and data required to demonstrate a medicine’s safety, efficacy, and quality. This advice can be sought at different stages of the medicine development process, from preclinical studies to clinical trials and post-approval activities. The advice the EMA provides aims to support companies in optimizing their development plans and addressing regulatory expectations.

On the other hand, for medical devices, the European Commission has established expert panels that are responsible for providing scientific advice in the context of clinical studies for high-risk medical devices. These expert panels assess the clinical evidence generated through clinical investigations or studies for medical devices within their respective areas of expertise. The advice provided by these panels helps inform the regulatory decision-making process and ensures that the clinical studies are appropriately designed and conducted to gather robust evidence on the safety and performance of the medical device.

The scientific advice 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.

Scientific advice plays a crucial role in guiding the development, evaluation, and regulatory decision-making for medicines and medical devices. It helps applicants align their development plans with regulatory expectations, optimize study designs, address scientific and technical challenges, and ensure the safety and efficacy of products before they reach the market.