The 2025 ISPE D/A/CH workshop on “Pharma’s Journey to Digital Manufacturing and Supply” united pharma leaders, technology experts, and regulatory authorities for three days of intense exchange on the digital transformation of our industry.
To accelerate the adoption of innovation in the global administration of the pharmaceutical industry, regulatory authorities and industry trade organizations must expand their scope and pursue a collaborative approach to recognition and reliance to streamline processes, enhance product quality, and improve patient access to medicines.
In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...
As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...
When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)
