Full Electronic Product Information In EU May Have To Wait Until 2030
A wide-ranging survey by Europe’s research-based pharma industry says moves towards replacing paper product information are gathering pace, although numerous challenges will need to be overcome.
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Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.
More agile regulatory processes, a much shorter period for the European Commission to make new drug approval decisions, and a firm legal basis for the European Medicines Agency in assessing combination products. These are among proposals put forward by Europe’s R&D-based pharmaceutical industry amid moves to revise the EU medicines legislation.
Coronavirus Notebook: Australia OKs Paxlovid, Lagevrio & Nuvaxovid, New Sputnik Data Show ‘Strong Protection’ Against Omicron
International regulators have broadened their discussions on the possible use of bivalent and multivalent vaccines, and the French presidency of the Council of the EU has called for “international solidarity” on vaccine provision.