1. First Board of Directors Meeting of the Asia-Pacific Self-Medication Industry (APSMI)
The first Board of Directors Meeting of the Asia-Pacific Self-Medication Industry (chairman: Seiichi Sato, CEO of Sato Pharmaceutical Co., Ltd.) was held on October 7, 2011 (Friday) at Rihga Royal Hotel Osaka. APSMI was established in November 2010, and the first Board of Directors Meeting had been scheduled for May of this year, but was postponed in the wake of the Great East Japan Earthquake.
At the Board of Directors Meeting, the member associations (board members of Japan Self-Medication Industry, China Nonprescription Medicines Association, Korea Pharmaceutical Manufacturers Association(KPMA) and The Taiwan Pharmaceutical Marketing & Management Association) and the board members of participating companies (8 companies) verified ongoing activities and reported on their financial status. This was followed by discussions on future activity plans and other topics.
We selected two projects, "regulation" and "self-medication," in order to realize information sharing and mutual understanding among the participating associations. We are preparing reports that summarize the conditions in individual countries.
Based on these reports, we are going to identify the problems that are common to member countries, as well as region-specific problems, and find solutions as a joint effort of the member associations. The outcomes of these processes will be presented to regulatory authorities, healthcare experts and consumers in order to contribute to the better development of the health industry in the Asia-Pacific region.
At this Board of Directors Meeting, the members came to the decision that the first APSMI General Assembly and the ninth World Self-Medication Industry (WSMI) Asia-Pacific Regional Meeting would be held in Seoul, South Korea in November 2012, hosted by KPMA with the cooperation of APSMI and WSMI.
2. MHLW published the Nortification of approval standards of anti-itchings and anti-inflammatory agents
The Ministry of Health, Labour and Welfare of Japan published the Nortification of new approval standards of anti-itchings and anti-inflammatory agents as OTC medicines as of November 1. The "anti-itchings and anti-inflammatory agents" in the approval standards refer to agents for epidermis that mostly consist of corticosteroids or antihistamines intended for anti-itch and anti-inflammatory effects. The approval standards specify types and amount of active ingredients that can be included, as well as indications, dosage and administration, and formulation. These standards will become applicable to products to be submitted after June 1, 2012.
As a general rule, prefectural governors have the power to approve medicines that are regulated under the approval standards. The approval standards in the past provided regulations for 14 drug classes including cold drugs, but after 13 years since the last revision, anti-itchings and anti-inflammatory agents were added to the approval standards as the 15th standard.
The standards for marketing approval of OTC medicines are specified for the following drug classes.
Cold remedies
Antipyretics and analgesics
Antitussives and expectorants
Gastrointestinal drugs
Purgatives
Anti-vertigo drugs
Ophthalmic agents
Vitamin preparations
Enemas
Anthelmintics
Nasal drops for rhinitis
Oral drugs for rhinitis
Topical antihemorrhoidals
Drugs for athlete’s foot and ringworm Anti-itchings and anti-inflammatory agents
3. "Learn well about OTC medicines and how to use them correctly" An event for dissemination and enlightenment of OTC medicines was held.
Six organizations in the pharmaceutical industry, Tokyo Home Medicine Manufacturer Association, Tokyo Yakuji Kyokai (Tokyo Pharmaceutical Regulatory Affairs Association), Tokyo Crude Drugs Association, Tokyo Pharmaceutical Association and Tokyo-to Iyakuhin Tourokuhanbaisha Kyokai (Tokyo Druggist Association), together with our association, hosted an event for dissemination and enlightenment of OTC medicines (sponsored by the Ministry of Health, Labour and Welfare and the Tokyo Metropolitan Government) at the Shinjuku Station West Exist Underground Plaza for two days from September 9 to 10. A total of 28 sponsor companies established public relations booths to advertise their products at this event.
Just like last year, a pharmacy offered samples of OTC medicines and explanations were given by pharmacists and registered retail person on the necessity of medicines, assisting visitors in better understanding medicines. At the adjoining "Medicine Consultation Corner," the Tokyo Pharmaceutical Association provided consultations to many visitors on topics including ethical drugs.
A space for measuring bone density, blood pressure and pulse rate for free was established for the first time and was popular among visitors. Again this year, Professor Watanabe of the Tokyo University of Pharmacy and Life Sciences conducted a consumer questionnaire. About one thousand people answered the questionnaire over two days, when combined with the quiz rally that was conducted in order to encourage visitors to move throughout the event space. The students of the Tokyo University of Pharmacy and Life Sciences were assisting the event by means of telling the story, with illustrated cards. The students also seemed to enjoy this valuable experience, one that they cannot encounter in their practical training at school. Radio stations covered the event, which saw more visitors than last year. The organizer announced that the number of visitors to the event was 35,000 people, an increase of about 20% from last year. We determined that we would prepare necessary exhibits and documents to be handed out to efficiently enlighten people about OTC medicines and self-medications though many events and opportunities.
