JETRO Topics
2nd Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices
September 2015
On September 10, JETRO co-organized the “2nd Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices” in its headquarters in Tokyo together with the Agência Nacional de Vigilância Sanitária (ANVISA) and the Pharmaceuticals and Medical Devices Agency (PMDA), as well as with the support of domestic industrial associations for medical devicess and pharmaceuticals. This event was held following the first open seminar under the same theme in Sao Paulo which was jointly hosted by the public and private sectors of both countries during the visit of Japanese Prime Minister Shinzo Abe to Brazil in August 2014. This year’s event was joined by Director President Jarbas Barbosa of ANVISA, who assumed office in July this year, and had an attendance of approximately 170 people from the public and private sectors of both countries, with Japanese manufacturers accounting for a significant portion.
With local authorities promoting reform of laws to optimize screening procedures, more expectations placed on early launch of improvement measures
In the opening session, representatives from organizers and supporting organizations as well as guests highlighted the fact that partnership between the two countries has been deepened in the field of medical regulations since the first seminar last year. They also expressed expectations for acceleration and optimization of screening procedures. In his welcome speech, Chief Executive Tatsuya Kondo of the PMDA congratulated ANVISA Director President Barbosa on his appointment. He also expressed his hope for lively discussions to be developed under a theme which is important both for regulatory authorities and the business world. Vice-Minister for Policy Coordination Katsunori Hara of the Japanese Ministry of Health, Labour and Welfare (MHLW) revealed the policy of his ministry to advance regulatory science and promote international harmonization of pharmaceutical regulations by facilitating key bilateral cooperation such as that between Brazil and Japan. ANVISA Director President Barbosa, who visited Japan for the first time since his inauguration in July, said that focusing on collaboration with other countries including Japan, ANVISA is encouraging international harmonization of regulations through partnership with relevant organizations such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the International Medical Device Regulators Forum. JETRO Chairman and CEO Hiroyuki Ishige introduced activities of Japanese companies interested in entry into Brazil, emphasizing the high praise they have received from hard-marker professionals such as local doctors and nurses. He also emphasized the commitment of JETRO to offering continued support for Japanese companies which are providing excellent products and services.
JETRO Chairman Ishige
ANVISA Director President Barbosa
PMDA Chief Executive Kondo
MHLW Vice-Minister for Policy Coordination Hara
Commemorative photo of representatives from organizers and supporting organizations
Scene of panel session
Venue packed with large audience
Outline
Organizer | Agência Nacional de Vigilância Sanitária (ANVISA), Japan External Trade Organization (JETRO), Pharmaceuticals and Medical Devices Agency (PMDA) |
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Supporter | Federation of Pharmaceutical Manufactures’ Association of Japan (FPMAJ), Japan Federation of Medical Devices Associations (JFMDA), Japan Pharmaceutical Manufacturers Association (JPMA) |
Date | September 10, 2015 |
Venue | JETRO headquarters |
Program | |
9:00- |
Welcome speech
|
9:40- | Photo session |
9:50- |
Making Japanese and Brazilian industries closer
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11:00- | Coffee break |
11:20- |
Enhancing review efficiency
|
13:05- | Lunch break |
14:25- |
QMS/GMP system and international collaboration
|
16:15- | Coffee break |
16:45- |
Pharmaceutical regulations of advanced therapy
|
17:45- |
Closing remarks
|