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2000年頃よりわが国の外資系製薬企業においては、既に欧米では確立している営業部門から独立したメディカルアフェアーズ(Medical Affairs:MA)部門を設立する動きが始まり、それに伴いエビデンス構築や社内外のステークホルダーに対して医学・科学的観点で高度な情報交換を行うメディカルサイエンスリエゾン(MSL)と呼ばれる職種も外資系企業が先行して導入しています。また2010年以降は、一連の臨床研究のデータ不正問題を受けて、内資系企業においても同様にMA部門の設立やMSLの導入が進められています。




MSL提言 原本 MSL_Recommendation_2017 JAPhMed_JP.pdf
MSLトレーニングカリキュラム一覧表 MSL curriculum table_ 2017 JAPhMed_JP.pdf
MA/MSL関連用語集 Glossary of MA and MSL_2017 JAPhMed(JP).pdf

Around the year 2000, among the foreign companies in the Japanese pharmaceutical industry, the division of Medical Affairs (MA), being independent of Sale & Marketing department and having been already established in the western countries, was commenced to set up. Then, beside Medical Affairs establishment, the sort of job, medical science liaison (MSL), who contributes to the medical evidence generation or provides and collects advanced medical and scientific information for both external and internal stakeholders, has been introduced. Regarding the domestic pharmaceutical companies, it has been tendency to set up MA and to introduce MSL ever since 2010 according to the scientific data fraud and ethical mal behavior in the publication of scientific journals.

Even though these roles, appropriate evidence generation and information exchange from medical/scientific perspectives, are very important, the outcome for MA is not clear, not such as sales figure in Sale Dept. or acquisition of drug manufacturing approval in R&D Dept. due to new business. Consequently, many companies repeat one trial and error after another to establish MA system and to receive the acceptance from internal/external stakeholders.

It is pivotal that the activities of MSL are positioned as a different role from sales promotion and that MSL must acquire medical and scientific expertise.
Therefore, commenced to discuss in 2014, the Japanese Association of Pharmaceutical Medicine (JAPhMed) established the system of accreditation for internal MSL certification programs organized by individual companies, as the third-party to be able to make a clear differentiation from their commercial dept, and to guarantee their advanced activities independently, in 2015. After publishing the Accreditation system, JAPhMed focused on the individual MSL and organized MSL task force team and the team discussed the definition of MSL, their qualification, KPI and required training curriculum. We named this statement, 'MSL recommendation' then presented as an interim report in 2016 and as a final report via the public seminar in 2017.
We publish all the report of MSL recommendation here.

MSL Recommendation original MSL Recommendation_2017 JAPhMed_EN.pdf
MSL Training Curriculum Table MSL curriculum table_2017 JAPhMed_EN.pdf
Glossary relating to MA/MSL Glossary of MA and MSL_2017 JAPhMed(EN).pdf


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