Ensuring timely access to innovative beneficial and safe medicinal products (hereinafter medicines) for patients is considered a key task of a health system and needs the collaboration of all its stakeholders, from lawmakers, regulators, physicians, patients, payers to, last but not least, the pharmaceutical industry. To reach this goal requires several steps, such as
- discovery and research of promising substances or their design (engineering) employing innovative methods,
- a well-planned and executed clinical development,
- efficient and fair regulatory processes,
- tailored access through appropriate programmes, adjusted to current knowledge during pre-authorisation phases
- integration of all these activities with subsequent price and reimbursement decisions and the pharmacovigilance activities for the entire lifecycle of medicines.