Conference Paper Good Practice for Introducing Radiopharmaceuticals for Clinical Use

藤林, 康久  ,  B, Abeysekera,  ,  R.J., Baxendale,  ,  A, Bhatnagar,  ,  U., Bhonsle,  ,  D.W., Dick,  ,  R.A.J, Dierckx,  ,  R., Donnell,  ,  A., Duatti,  ,  M., Ehrenfried,  ,  El-Haj,, N.  ,  S, Fanti,  ,  M.M., Graham,  ,  V., Kumar,  ,  S.T., Lee,  ,  Miller, R., Nunez  ,  R., Pasqualini,  ,  D., Paez,  ,  D., Soloview,

BACKGROUNDRadiopharmaceuticals are radiolabelled compounds designed to deliver diagnostic information as a result of their incorporation with selected cellular targets. These exquisite molecular tools are essential components of nuclear medicine technology and must be prepared prior to administration to the patient. The production of radiopharmaceuticals must be performed by al icensed commercial organization,or altematively using in-house good manufacturing practice (GMP) compliant facilities. According to the mostwidely accepted defmition,a radiopharmaceutical is classified as a‘ medicinal product' and,therefore,its production,characterization and quality control testing should comply with the rules for manufacturing/compounding sterile products intended for human injection. These rules have evolved over the years to ensure that a safe and high quality product is adrninistered to the patient at all times. In countries that are experienced in this technology,the most common route ofsupplying radiopharmaceuticals is through a network of commercial production sites. In this context,the commercial producer retains the responsibility of ensuring that the quality and safety of leradiopharmaceutical product complies with intemationally accepted standards. However,i n-house preparations are also permitted when performed in aGMP compliant facility. Positron enlIssion tomography (PET) and single-photon emission computed tomography (SPECT) radionuclide diagnostic imaging,are complextechnologies that require certain infrastructure to be in place before the population of a country can benefit from their application. In many countries where these technologies have been developed and used in clinical practice for some time,the necessary components are already established. These include but are not limited to (a) the manufacture of radiopharmaceutical to a GMP standard,(b) a clear gularatory framework,(c) availability of scanning centres and (d) suitably qualified personnel. Countries with less extensive experience in the mannufacture of radiopharmaceuticals may encounter several challenges,which,in the first instance, include a basic lack of expertise.In addition,there may also be a lack of clarity with respect to the rules and guidance regarding the process of technological development.11.2 JAPANThere are two types of radiopharmaceuticals in clinical usage, namely approvedradiopharmaceuticals and compounded radiopharmaceuticals produced by approved synthesis modules. The Ministry of Health, Labour and Welfare (WHL W) and the Pharmaceutical and Medical Device Agency (PMDA) are responsible for the approval of radiopharmaceuticals and medical devices. For these radiopharmaceuticals GMP, GCP and good laboratory practice(GLP) are required in the production and delivery processes, pre-clinical safety testing and clinical trials, respectively. Radiophannaceuticals should be produced using an approved synthesis module and all the process and quality assurance should be done according to the guidelines and monographs published by a scientific organization (Japanese Society of Nuclear Medicine (JSNM). Recently, the JSNM Molecular Imaging Strategic Committee (JSNM-MISC) published"New Guidelines and qualification for research using in-house PET drugs", including a guideline for the standardization and quality assurance of in-house PET drugs; guidelines for standardization and quality control of PET imaging; guidelines for the clinical evaluation of PET drugs and guidelines for pre-clinical safety tests of PET drugs. JSNM-MISC is also working on developing and publishing new radiophannaceuticals monographs. This is to facilitate safe and effective clinical research, as well as approval of synthesis modules for newradiopharmaceuticals. JSNM-MISC and National Institute of Radiological Sciences have started an educational program for PET radiopharmaceuticals production under the JSNMGuidelines that operates site-visit programs for audit, and closely communicates with government authorities to harmonize the guidelines and government regulations.

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