Revision of the Japanese Pharmaceutical Affairs Law: New Regulatory Framework of Regenerative Medicines – 11th DIA Japan Annual Conference
Reporter: Gerard Loiseau, ESQ
Akiko Hihara, Managing Editor, Regulatory Intelligence, Thomson Reuters
The 2 acts make a turning point for developing and marketing regenerative medicines in Japan. Some significant points include:
Law No. 84/2013:
- Product approval based on the laws is required from now on.
- Expedited approval system is introduced for regenerative medical products. Law No. 85/2013:
- It became mandatory for medical institutions to submit plans of research and treatment.
- It became possible to provide the products from other than medical institutes. In other words, cell culturecan be contracted to a cell culture factory, for example.
- A license system for a cell processing center (CPC) is introduced that should comply with GCTP (Good gene, Cell & Tissue Practice) regulating quality risk management; manufacturing control; quality control; and facility requirements of gene, cell, and tissue products.
Huge impact on R&D and marketing is expected from this new regulatory framework. Both academia and industry were excited about exploring the new opportunities in research and business.
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Other Articles and e-Books on Regenerative Medicine Published in this Open Access Online Scientific Journal include the following:
Series A: e-Books on Cardiovascular Diseases
Series A Content Consultant: Justin D Pearlman, MD, PhD, FACC
VOLUME FOUR
Regenerative and Translational Medicine
The Therapeutic Promise for
Cardiovascular Diseases
by
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