Affiliations: Pharmaceutical Technology Department, Faculty of
Pharmacy, Universidad de Granada, 18071 Granada, Spain. Tel.: +34 958
243898/99; E-mail: [email protected]
Abstract: Major progress has been achieved over the last years in EU.
Legislative initiatives have led to improved marketing authorisation
procedures, the harmonisation of data protection in the EU, better access to
medicines for children, and a new regulatory framework for advanced therapies.
Nevertheless stakeholders continue to raise concerns with regard to the market
fragmentation linked to disparities in national pricing and reimbursement
schemes, unnecessary regulatory burdens caused by divergences in the
implementation of Community legislation, and divergence in interpreting the
relevant legislation and cumbersome procedures for multi-centre clinical trails
in different Member States. New legislation are preparing. Establishing and
enforcing international public health standards is essential to minimise the
risk that unsafe products enter the EU market.
Keywords: Pricing, active substances, clinical trails, unique identifier, global cooperation, harmonisation