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Market trends
Japan is the largest biomedical market in the Asian Pacific market (making up more than 60 per cent) with revenues over US$15 billion. More than 30 per cent and 25 per cent were attributed to the medical sector and food and agriculture sector respectively. The biomedical research capabilities are also the most advanced in the region. There are biomedical clusters in Tokyo, Osaka and other major cities.
Leading companies include:
- Takeda Pharmaceuticals – a 225-year old company founded in 1781, specialises in the R&D, manufacturing and marketing of a wide range of human therapeutics globally.
- Daiichi-Sankyo – a major pharma company specialising in human therapeutics covering cardiovascular, diabetes, oncology, bone, joint and pain, infectious and allergic diseases.
- Kyowa Hakko Kogyo Co. – specialises in the development of pharmaceuticals, agrochemicals, animal health, alcoholic beverages and chemicals.
- Takara Holdings – the parent company to Takara Shuzo and Takara Bio. Takara Shuzo produces alcoholic and non-alcoholic beverages. Takara Bio provides gene research (eg. glycobiology, immunotherapy, gene therapy and genome analysis) and reagents for gene research. The company markets a wide range of products that support genetic research.
- Meiji Seika Kiasha – a dominant player in the functional food and wellbeing sector and is now in the R&D of biopharmaceutical compounds.
The Pharmaceutical and Medical Safety Bureau (Ministry of Health, Labour and Welfare) is the agency responsible for clinical experiments, technical examinations for registration and after-sales follow-ups, to secure the safety, efficacy of pharmaceuticals and medical devices in Japan.
In terms of clinical examinations (the last stage of the development of pharmaceuticals), ‘Standards on the Implementation of Clinical Trials on Drugs (New GCO)’, was fully enacted in April 1998 aiming to satisfy scientific and ethical requirements.
In the meantime, efforts for smooth implementation of clinical examinations are also being promoted, including the establishment of a system to invite positive participation of subjects in clinical examination and the improvement of a system of medical institutions conducting clinical examinations.
Technical examinations for registration are covered by the Drug and Medical Device Examination Centre. The centre gives and promptly completes examinations that can stand comparison with those in Western nations.
Japan is also party to the ‘International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use among the US and the EU’.
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