Regulatory

Recent trends in the regulatory landscape and healthcare could significantly impact the pharmaceutical industry. Expansion of Therapeutic Modalities: The modality landscape is broadening beyond traditional small molecules and proteins to include peptides, antibody-drug conjugates, nucleotide-based therapies (especially antisense oligonucleotides, siRNAs, and mRNAs), radionuclides (theranostics) and cell and gene therapies. This diversification brings new preclinical and drug development requirements and additional regulatory complexities.  For example, the complexities of bringing a radionuclide to market are amplified when regulatory agencies must cope with the fact that most radioactive therapeutics need to be used within one week – and often the same day – that they are manufactured.  These requirements necessitate regulation at the level of the radionuclide generator itself (68Ga and 99mTc) or as radionuclide precursor formulations (177Lu, 111In, 64Cu, 90Y) due to the sophisticated infrastructure involved. Increased Focus on Digital Technology: Regulatory changes in 2024 aim to clarify technology and data collection rules. This includes updates to the International Council for Harmonisation's…