Radiopharmaceutical Preparation and Quality Control: Technical Documents Submission Guidance 1st Edition (2025)

In-line with Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, Ministry of Health (MOH) has taken the initiative to ensure the preparation and quality control activities of new radiopharmaceuticals are conducted safely and effectively. This approach is not only guided by PIC/S standards but is also supported by recent publications from the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI), the European Association of Nuclear Medicine (EANM) and the International Atomic Energy Agency (IAEA), which provide additional guidance on the preparation of radiopharmaceuticals.

Hence, the technical report on the preparation and quality control of radiopharmaceuticals is one of the requirements that must be fulfilled by the nuclear medicine facilities when applying for new radiopharmaceutical use in their facilities. The publication of this guide is timely to facilitate pharmacists at nuclear medicine facilities to submit relevant documents for the preparation of technical report systematically.

Kindly refer to the checklist for the application of Technical Report Part 1 and Technical Report Part 2 (if relevant). All technical report applications by the nuclear medicine facilities must comply with the procedures set out in this guide and shall be emailed officially to the Director of Pharmacy Practice and Development Division, MOH and Deputy Director of Pharmaceutical Care Branch, Pharmacy Practice and Development Division, MOH.