European Pharmaceutical Review

JUNE 19, 2025

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. Since establishing a dedicated pathway for biosimilars in 2004, the EU has aimed to balance rigorous evaluation with the practicalities of fostering competition and improving patient access to biologics.

Biosimilars 97

Biosimilars Packaging Documentation Drug Development 97

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

Integra X Files

DECEMBER 19, 2022

Industry representatives spent many hours during 2004 discussing the needs of nursing home residents and the current standards of service. The document also requires plans to provide a transition period for non-formulary drugs to ensure beneficiaries have continuous access to required medications.

Nursing Homes 52

Nursing Homes Documentation Dosage Packaging 52

European Pharmaceutical Review

APRIL 14, 2025

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. Under the Human Tissue Act 2004.

Hospitals 52

Hospitals Documentation Packaging Communication 52