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Osteochondrosis dissecans typ 2 verneinung

The Japanese regulatory framework for pharmaceuticals and medical devices has recently been reexamined and the revised Pharmaceutical Affairs Law, which has been renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, was developed in 2013 and implemented in November 2014.Therefore, promoting regenerative medicine can be expected to become a new focus for patients who suffer from incurable diseases and injuries.However, because regenerative medicine utilizes ingredients derived from living cells and tissues, it carries a risk of bacterial or viral infection and tumorigenicity.Regenerative medicine is a method to treat diseased or damaged organs using stem or somatic cells and tissues.Based on these changes to the regulatory framework for regenerative medical products in Japan, this article aims to examine how this framework could be utilized as an appropriate system to develop innovative regenerative medicine.The RMP Act aims to comprehensively promote the use of regenerative medicine by ensuring its safety.As part of emergency economic policy measures (January 11, 2013; Japanese Cabinet Decision), the reexamination of a special expedited reviewing system for regenerative medical products was initiated.

Based on this new legal framework, Japan will have the potential to become a prime venue for international medical researchers and industries .It is therefore imperative that sufficient safety measures are established in parallel with the promotion of regenerative medicine.Following the implementation of the new Act, the Good, Gene Cell and Tissue Manufacturing Practice was established to address the different requirements and concepts for appropriate research and development of regenerative medical products.Following the introduction of this Act, the government submitted the PMD Act, which is the revised version of the Pharmaceutical Affairs Law [2] and [6].Since 2011, the regulatory frameworks for pharmaceuticals and medical devices in Japan have been reexamined and the revised Pharmaceutical Affairs Law, which was renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act), was developed in November 2013 and implemented in November 2014 [2] and [3].

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