Japanese pharmaceutical and regulatory environment
نویسندگان
چکیده
Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.
منابع مشابه
CELL & GENE THERAPY INSIGHTS NAVIGATING THE GLOBAL REGULATORY LANDSCAPE REGULATORY INSIGHT Japan’s regulatory gamble and what it means for the Industry
On November 20th 2014, the Japanese legislature passed the new Act on the Safety of Regenerative Medicine (ASRM) and the revised Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) [1]. It is hard to make that sentence sound exciting, but what many outsiders have yet to fully appreciate is the tectonic shift in Japanese pharmaceutical regulatory policy this represents...
متن کاملJapanese Government Policy in Pharmaceutical to Innovative R & D Industry
The Japanese pharmaceutical industry has been growing steadily since the 1970's. The early success, however, largely depended on technological "diffusion" including technology transfer or licensing of competitive foreign pharmaceutical products followed by development of incremental drugs which largely contributed to the early prosperity of domestic industry. Recently, transformation in distrib...
متن کاملEffect of Varying Protein Levels and Preservation Methods and Duration on Egg Production Performance and External Egg Qualities of Japanese Quails in a Semi-Arid Environment
The study was conducted to determine the effect of varying protein levels and preservation method on external egg qualities of Japanese quails. A total of 180 birds were randomly allotted into three dietary treatments in a completely randomized design (CRD) replicated six times. A factorial arrangement of 3 × 4 × 4 which involves 3 protein levels (15, 20 and 25% crude protein), 4 storage method...
متن کاملPharmaceuticals in the environment: scientific evidence of risks and its regulation.
During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for hu...
متن کامل