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

Main Article Content

Wittawat Viriyabancha
Sataporn Lumpaiboonsuk
Pramote Akarapanon
Suchart Chongprasert

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.

Downloads

Download data is not yet available.

Article Details

Section
Research Article

References

1. Hanna E, Rémuzat C, Auquier P, Toumi M. Advanced therapy medicinal products:current and future perspectives. Journal of Market Access & Health Policy 2016; 4(1):31036.

2. Hourd P, Chandra A, Medcalf N, et al.Regulatory challenges for the manufacture and scale-out of autologous cell therapies. 2014 Mar 31. In: Girard L, editors. StemBook
[Internet]. Cambridge (MA): Harvard Stem Cell Institute; 2008.

3. Hurley P, Jurmeister S, Parsley K. Advanced therapy medicinal products - an evolving regulatory landscape. Regulatory focus 2017; 1-7.


4. Halioua-Haubold CL, Peyer JG, Smith JA,et al. Regulatory considerations for gene therapy products in the US, EU, and Japan. The Yale Journal of Biology and Medicine
2017, 90(4): 683–693.

5. O’Brien D. The importance of product classification [PowerPoint slides]. Irish Medicines Board; 2012.


6. US Food and Drug Administration. Guidance for industry: Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), small entity compliance
guide, 2007.

7. Gadriock P. HCT/P regulation – 351 vs 361 products [PowerPoint slides]. Arent Fox; 2017.


8. Oh SS. FDA’s perspectives on cellular and gene therapy regulation [PowerPoint slides]. International Regulatory Forum of Human Cell Therapy and Gene Therapy Products; 2016.

9. Berseney A. (2014). FDA clarifies minimal manipulation of cell/tissue products. Stem Cell Assays [Internet]. 2014.


10. US Food and Drug Administration. Guidance for industry and food and drug administration staff: Regulatory Considerations for human cells, tissues, and cellular and tissue-based products: Minimal manipulation and homologous use, 2017.

11. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive
2001/83/EC and Regulation (EC) No 726/ 2004 (L. 324/121-137).

12. Bravery CA. EU vs US Regulation impact on global development [PowerPoint slides].


13. Ministry of Health, Labour and Welfare. Institutional framework for promoting the future implementation of regenerative medicine [PowerPoint slides].


14. Maruyama Y. Regulation of regenerative medicine in Japan [PowerPoint slides].Health Products Regulatory Conference; 2017.


15. Tobita M, Konomi K, Torashima Y, et al. Japan’s challenges of translational regenerative medicine: Act on the safety of regenerative medicine. Regenerative
Therapy 2016;4:78-81.

16. CJ Partners. Regenerative medicine in Japan [PowerPoint slides]. CJ Partners; 2016.


17. ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง การควบคุม กำกับ ดูแลยาที่เป็นผลิตภัณฑ์การแพทย์ขั้นสูง (ลงวันที่ 7 มีนาคม 2561).