A Study on Regulatory System Development for Advanced Therapy Medicinal Products: Product Classification

Abstract

Nowadays, the trend on research and development for Advanced Therapy Medicinal Products (ATMP) such as stem cell products, cell therapy medicinal products, gene therapy medicinal products, etc., has become risen up due to attention paid by research units from private and government sectors according to their precision and specific characteristics to patients and illnesses or diseases. However, due to the complexity of manufacturing or manipulating process for products and also their mechanism of action which can be classified as high risk products, many countries have necessarily considered setting up an appropriate regulatory system forthese kinds of products. In order to develop a regulatory system appropriate to ATMP, product classification could be considered as one of the most important components for the regulatory system. Therefore, this study has analyzed ATMP classification system from leading countries such as United States of America, European Union and Japan. Regarding the regulatory analysis from selected countries, the suggested product classification system for Thailand has been developed based on risks of the products both from their manufacturing process and their uses, and the national regulatory agency should regulate mainly on high risk products. With regard to this reason, Thai Food and Drug Administration should issue a guideline describing manufacturing processes or product uses that need to be approved by the agency, in order to effectively leverage consumer protection. Moreover, based on our analysis, it is worth noting that classifying ATMP into subtype products would be beneficial for the regulatory system by categorizing the type of products as follows; cell therapy medicinal product, gene therapy medicinal product, tissue engineered product and combined advanced therapy medicinal product, as it could later help support specific regulation in each type of products.