EMA-SAWP

The Scientific Advice Working Party (SAWP)

The Scientific Advice Working Party (SAWP) is a standing working party within the European Medicines Agency (EMA). It was established by the Committee for Medicinal Products for Human Use (CHMP).

The SAWP has the following main roles:

• Providing Scientific Advice: SAWP offers scientific advice to pharmaceutical companies on the development of new medicines. This advice helps ensure that the studies and tests conducted are appropriate and robust, ultimately supporting the development of high-quality, effective, and safe medicines.
• Protocol Assistance: For orphan medicines, which are intended to treat rare diseases, SAWP provides protocol assistance. This includes advice on the demonstration of significant benefit within the scope of the designated orphan indication.
• Qualification of Novel Methodologies: SAWP supports the qualification of innovative development methods, such as new biomarkers or digital methodologies, ensuring they are scientifically validated and can be used in the development of new medicines.

The EMA-SAWP contributes to the validation of New Approach Methodologies (NAMs) through several key activities:

• Scientific Advice and Qualification: SAWP provides scientific advice on the development and validation of NAMs. This includes evaluating the scientific rationale and preliminary data, and issuing qualification opinions or advice on the acceptability of these methodologies for specific uses in pharmaceutical research and development.
• Public Consultation: Before adopting qualification opinions, SAWP opens its evaluations for public consultation. This allows the scientific community to scrutinize and discuss the methodologies, ensuring transparency and scientific rigor.
• Collaboration and Support: SAWP collaborates with various stakeholders, including industry, academia, and other regulatory bodies, to promote the development and acceptance of NAMs. This collaboration helps in sharing data and facilitating studies aimed at eventual qualification.

For additional support or helpdesk information, you can reach out to the SAWP directly through the EMA contact page. They offer resources and support for questions about the development and validation of NAMs.