12/06/2017
Message from Chairman of the JAPAN KAMPO MEDICINE MANUFACTURERS ASSOCIATION regarding the change in status of a number of Kanpo medicines from Rx to OTC.
Given the wide-ranging business domains of its member companies, the Japan Kampo Medicines Manufacturers Association (hereinafter referred to as “JKMA”) has organized five industrial commissions and six functional committees to carry out its activities.
This year 2016 is the final year of its “2012 Medium-to-Long-Term Business Plan (Five Year Plan),” and its priority issues are to “Strengthen the quality assurance of crude drugs and finished products that are produced from crude drugs as raw materials,” and “Promote a stable procurement of raw materials for crude drugs.”
For the promotion of domestic cultivation in Japan, JKMA held a conference, “Block Conference for Expansion of Domestic Cultivation of Medical Crops” for the third consecutive year since 2013. Over the three-year period, JKMA received 345 request forms and negotiated 96 of them with companies in order to discuss the possibility of test cultivation. “For the Production Region Creation Support Project for Local Specialty Products Including Medical Crops” organized in 2016 by the Ministry of Agriculture, Forestry and Fisheries, JKMA jointly established a council with the Japan Agricultural Development and Extension Association and began to act as a point of contact for preliminary consultations in reference to the production region creation of the domestic cultivation of crude drugs.
To ensure the stable procurement of approximately 80% of raw materials for crude drugs from China, traditional medicine related groups in China and Japan have been visiting each other’s country every other year to promote communication and strengthen cooperative relationships. In 2016, JKMA visited China to coincide with “7th HNC Expo 2016 - Healthplex & Nutraceutical China 2016” that was held in Shanghai in June. In 2015, a national-level project was established in China that focuses on the cultivation of crude drugs and the improvement of manufacturing techniques and quality. In February 2016, China announced its development plan for traditional Chinese medicines and medical services. Improving the quality criteria of traditional Chinese medicines, the development plan is now executing speedily to strengthen both medicines and medical services as well as raw materials for crude drugs. JKMA also shared relevant information with associated groups.
With reference to international standardization, the seventh plenary meeting of ISO/TC 249 “Traditional Chinese Medicine” was held in Rome in June 2016. It was the first meeting since the ISO Technical Management Board approved its title and scope. Members conducted a livelier discussion than those they had held in the past. To ensure compliance with the regulations for Japanese Kampo formulations, crude drug products and crude drugs, JKMA reviewed the structure of “International Working Group” so that it is able to examine work items from the perspective of experts timely, welcomimg new members to the WG in April 2016.
As for OTC Kampo products, the Rx-to-OTC switch will take place in January 2017 for 82 ingredients, and they will become tax deductible. The rise in “self-medication” awareness among the general public is expected to change the behavior towards OTC purchases. JKMA determined to create an environment that enables it to secure their quality and safety, to provide OTC Kampo products and crude drug products that meet people’s needs, and to contribute further to public health.
JKMA has been exchanging opinions with local governments and related associations with reference to ethical Kampo products, the role they must continue to play in national medical care. We reached the conclusion that it would be necessary to disseminate common understanding among academia, related associations, related administrative agencies, the public and patients, and raise the overall profile of Kampo by gaining furthermore understanding. As we pursue these initiatives while JKMA plays a central role, we wholeheartedly ask for your continuous support and understanding.
The year 2016 represents a major milestone, because it is the 40th year since ethical Kampo products were added to the classification of drugs by efficacy as prescription products. As essential drugs, the role they play in national medical care is growing. We can only think that this is a result of the continued efforts made by those who worked before us. We are determined to perform our mission in order to continue to contribute to national medical care.
We would be most grateful if you could provide us with your continuous support and understanding.
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