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.

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JETRO Chairman Ishige

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ANVISA Director President Barbosa

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PMDA Chief Executive Kondo

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MHLW Vice-Minister for Policy Coordination Hara

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Commemorative photo of representatives from organizers and supporting organizations

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Scene of panel session

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Venue packed with large audience

Outline

Organizer Agência Nacional de Vigilância Sanitária (ANVISA), Japan External Trade Organization (JETRO), Pharmaceuticals and Medical Devices Agency (PMDA)
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
  • Dr. Tatsuya Kondo, Chief Executive, PMDA
Opening remarks
  • Mr. Katsunori Hara, Vice-Minister for Policy Coordination, Ministry of Health, Labour and Welfare (MHLW)
  • Dr. Jarbas Barbosa, Director President, ANVISA
  • Mr. Hiroyuki Ishige, Chairman and CEO, JETRO
  • Mr. Masafumi Nogimori, President, FPMAJ
  • Mr. Fumio Suzuki, Vice President, JFMDA
  • Mr. Joffre Moraes, Regulatory Affairs Strategy Manager, Associação Brasileira da Indústria de Artigos e Equipamentos Médicos, Odontológicos e de Laboratórios (ABIMO)
9:40- Photo session
9:50- Making Japanese and Brazilian industries closer
  • Moderator
    • Mr. Keiya Iida, Assistant Minister for Promotion of Healthcare Industries and Global Expansion of Healthcare, MHLW
  • Updates from JETRO São Paulo
    • Mr. Yasuhiro Ishida, Director Presidente, JETRO SÃO PAULO
  • Updates from Medical Devices Association
    • Mr. Carlos Alberto Pereira Goulart, Executive President, Associação Brasileira da Indústria de Alta Tecnologia de Produtos para Saúde (ABIMED)
    • Mr. Joffre Moraes, Regulatory Affairs Strategy Manager, ABIMO
Q&A
11:00- Coffee break
11:20- Enhancing review efficiency
  • Moderator
    • Dr. Toshiyoshi Tominaga, Associate Executive Director (for International), PMDA
  • Medical devices
    • Mr. Bruno Rios, Superintendent of Inspection, ANVISA
    • Mr. Yasutaka Watanabe, Director, Office of Medical Devices III, PMDA
  • Pharmaceuticals
    • Mr. Naoto Kato, Deputy Office Director, Office of Review Management, PMDA
    • Ms. Meiruze Freitas, Superintendent of Medicines, ANVISA
Panel discussion
13:05- Lunch break
14:25- QMS/GMP system and international collaboration
  • Moderator
    • Dr. Shingou Sakurai, Office Director, Office of Manufacturing/Quality and Compliance, PMDA
  • Medical devices (Japan)
    • Ms. Naoko Sato, Deputy Director, Office of Manufacturing/Quality and Compliance, PMDA
  • Pharmaceuticals (Japan)
    • Dr. Ryoko Naruse, Director, Office of Manufacturing/Quality and Compliance, PMDA
  • Medical devices and pharmaceuticals (Brazil)
    • Mr. Bruno Rios, Superintendent of Inspection, ANVISA
Panel discussion
16:15- Coffee break
16:45- Pharmaceutical regulations of advanced therapy
  • Chair
    • Dr. Nobumasa Nakashima, International Planning Director (c/o Evaluation and Licensing Division), MHLW
  • Advanced therapies and ANVISA's experience in compliance of new drugs
    • Ms. Meiruze Freitas, Superintendent of Medicines, ANVISA
  • Advanced therapies and experience of Sakigake in approval of innovative drugs
    • Mr. Kazuhiko Mori, Director, Evaluation and Licensing Division, MHLW
17:45- Closing remarks
  • Dr. Jarbas Barbosa, Director President, ANVISA
  • Mr. Kazuhiko Mori, Director, Evaluation and Licensing Division, MHLW