Advancements in drug manufacturing ... format within the International Council for Harmonisation (ICH) framework is helping bring greater consistency to regulatory submissions.

Harmonization ... in regulatory requirements can force medicine and NAM developers to perform redundant studies to meet differing standards. Initiatives such as the recent International Medicines ...

that even as the global push for harmonisation continues, companies cannot afford to lose sight of local requirements. There remain critical differences in drug and device regulations between ...

Evidence obtained from biomarker studies showing that a drug ... on the requirements of their validation process. This will be supported by the ongoing dialogue on harmonization of regulatory ...

PITTSBURGH, April 15, 2025 (GLOBE NEWSWIRE) -- Matthews International Incorporation ... foreign anti-trust and competition authority regulatory requirements. As a result, the parties anticipate ...

Rare diseases, often referred to as orphan diseases, affect small patient populations, yet collectively they impact more than ...

Pharmacovigilance evolves with technology, employing active surveillance to detect drug-related issues and ensure safety in ...

by the central drug regulatory body in the latest round of survey. Further, govt said, one drug sample from the state of West Bengal was identified as a spurious drug, which was manufactured by ...

In this article we look at global regulatory efforts to re-position market structures and ensure effective compliance ...