Representatives of member companies from the pharmaceutical sector shared comments and recommendations on the proposed provisions, highlighting the need for further clarification and refinement in several areas to ensure a predictable, efficient, and transparent regulatory framework.

The discussion focused on the importance of maintaining high regulatory standards while improving access to medicines and strengthening the overall efficiency of the system. Members emphasized that any regulatory changes should preserve a balance between facilitating availability of medicinal products and ensuring robust safeguards for quality, safety, and efficacy.

Particular attention was given to alignment with internationally recognized regulatory frameworks and reliance on stringent regulatory authorities. Members also emphasized the importance of Good Manufacturing Practice (GMP), including EU GMP standards, as a key requirement for market authorization and product safety.

Participants also underlined the importance of legal clarity in authorization procedures and documentation requirements, as well as the need for consistent and predictable application of rules related to marketing authorizations and product registration pathways.

The Committee further highlighted the importance of ensuring clear and transparent regulatory processes for medicinal products, including biological and generic medicines, in order to support patient access while maintaining high standards of public health protection.

The meeting concluded with a shared view on the importance of continued engagement with stakeholders to support a regulatory environment that is efficient, transparent, and aligned with international best practices, while safeguarding patient safety and supporting sector development.