The mission of the Pricing & Economics Committee, or PEC, is to participate in discussions on a wide range of economic issues relating to the pharmaceutical business especially in regards to establishing a better pricing and a better healthcare system. To achieve this goal, the PEC actively engages in talks on healthcare system reform with the Japanese government, other industrial associations, and related stakeholders on behalf of European pharmaceutical companies in Japan.
The Technical Committee works to improve the regulations as well as development and evaluation techniques that affect the innovative pharmaceutical industry and the implementation of those regulations. The aim is to ensure the rapid access by Japanese patients to safe and effective treatments.
Contributions to the development (clinical trials) environment: The Clinical Subcommittee regularly conducts investigations of the clinical trials environment in order to confirm changes in the environment and make recommendations based upon those changes. The Anti-cancer Drug Subcommittee makes proposals focused on the environment for implementing clinical trials of anti-cancer drugs, while also working in coordination with governmental and academic parties to participate in and make contributions through the "forum for the development of medicines to combat malignant tumors" which discusses various issues in the development of anti-cancer drugs.
Contributions to the regulatory affairs environment: Each subcommittee and task force is involved in investigating problem points and conducting interviews to gather opinions and requests regarding related regulations, guidelines and Q&As, as well as newly issued proposals in connection to the above, so as to resolve or make recommendations regarding such matters. The Product Quality subcommittee facilitates the appropriate and efficient implementation of submission and review of new drugs developed outside Japan and LCM of approved drugs manufactured outside Japan.
Contributions to technology: The Safety/PMS Subcommittee contributes to improvements in systems for monitoring the safety of Japanese pharmaceuticals through projects involving the participation of regulatory authorities and other pharmaceutical industry groups. The Pharmacokinetics/Pharmacodynamics Task Force (PK/PD TF) contributes to advance global development through activities including cooperation in Ministry of Health, Labour and Welfare-led investigations into differences between different ethnic groups. The Non-clinical Sub-committee contributes to improved evaluations based on the sharing of information, the organization of study meetings, and cooperation in the Pharmaceutical Evaluation Forum.
Materials for TEC Activities
- Requirements for source documents in clinical trials -ALCOA principles- 【only in Japanese】(PDF)
- ALCOA best practice 【only in Japanese】(PDF)
- ALCOA Case study 【only in Japanese】(PDF)
- Recommendation of On Off-site Monitoring Process 【only in Japanese】(PDF)
- Action list for On Off-site Monitoring 【only in Japanese】(PDF)
- "15th Conference on CRC and Clinical Trials 2015 in KOBE –Presentation Materials of PhRMA/EFPIA Joint Seminar" materials【only in Japanese】（PDF）
CS3-1 CS3-2 CS3-3
- "16th Conference on CRC and Clinical Trials 2016 in Omiya –PhRMA/EFPIA Joint Seminar Results of questionnaire on role division and collaboration of medical institutions and clinical trial sponsors completed by CRCs and CRAs【only in Japanese】(PDF)
- "Guidance and checklist for collaboration between Sponsor and CRO through clinical trials"【only in Japanese】 (General statement: PDF) (Tool: PDF)
- Results of clinical trial environmental survey in 2016【only in Japanese】(PDF)
- Special or specified medical care coverage system【only in Japanese】(PDF)
- Compensation for cooperating in a clinical trial【only in Japanese】(PDF)
- Payment method of investigator fee【only in Japanese】(PDF)
- Business Continuity Plan (BCP) for clinical trial at large scale disasters【only in Japanese】(PDF)
The Access Committee examines broad trends related to Market Access and the Health Technology Assessments (HTA) in Japan. Its primary goal is to ensure that HTA guidelines are formulated and implemented in a manner that values innovation and promotes greater patient access. The Access Committee wishes to ensure that global best practices related to HTA are understood by policymakers and adopted in Japan. These best practices include a transparent HTA review process, a robust dialogue between industry and government, and a health care system that continues to encourage the rapid introduction of safe and effective medicines for patients. The Committee develops materials for external stakeholders and meets with policymakers to explain the EFPIA positions on HTA and other market access issues, including the 14 Day Rule.
Governance and Legal Committee, newly established by the merger of Corporate Ethics Committee and Intellectual Property and Legal Committee, covers legal, ethics and compliance area of business in which member firms are required to be adaptive to changes in business environment. Governance Legal Committee keeps its predecessors as two working groups (WG).
Corporate Ethics WG: Makes proposals to enable member firms to conduct business in compliance with a proper level of ethics and compliance standard. Facilitates compliance workshops where member firms can exchange its opinions on ethics and compliance in the pharmaceutical industry. On behalf of EFPIA Japan, closely and proactively working with Japan Pharmaceutical Manufacturers Association and other healthcare industry associations, promotes a level of business compliance in the pharmaceutical industry in Japan.
Intellectual Property and Legal WG: Investigates and studies the latest legislations, regulations and IP strategies in the healthcare industry in Europe as well as Japan. Exchanges opinions with member firms and industry associations, and makes proposals relating to Intellectual Property and legal matters. Contributes to the advancement of healthcare industry legislations and regulations in Japan.
The Biologics Committee engages in a wide range of activities, covering treatments that have already been commercialized such as protein-preparations and antibody-based medicines created using genetic recombinants and other techniques, treatments based on next-generation medical technology that can hopefully be commercialized in the future such as products for regenerative medicine as well as nucleic acid-based pharmaceuticals, blood products including blood-related genetically-modified products, and vaccines. Three subcommittees, divided according to product group, are engaged in the following activities in order to improve the technical and regulatory environment for development, manufacturing, supply and safety monitoring.
Blood Product Subcommittee (BPSC): BPSC aims to establish a stable supply process for “Plasma Derived Products” manufactured from human blood and for essential products in medical care, and for any plasma related recombinant products that are manufactured with the world’s most advanced technology. With an eye to the future, the BPSC is also pursuing recommendations and dialogues with the Japanese Government to solve issues such as a lack of blood donors, and a production and supply process for plasma derived products during both normal times and emergencies.
Vaccine Subcommittee: In recent years, innovative overseas vaccines have been approved and come into use in Japan, and a considerable improvement has been achieved in the vaccine gap versus overseas countries. However, many areas still require work, including certain systemic issues such as the continued inability to use certain pediatric vaccines in Japan as well as low rates of vaccination. The subcommittee makes proposals to resolve these issues and works to provide good vaccines more promptly and more broadly in Japanese clinical settings.
Biological Products Subcommittee: Biological products are diverse but hold out great hope of new and innovative treatments. Among important issues are the future positioning of biosimilars as well as regenerative treatments including genetic treatment. The subcommittee harnesses the experience and track record of EFPIA in Europe in order to evaluate various different issues and produce recommendations.
The Public Relations Committee works to inform healthcare stakeholders, including patients, the general public, medical professionals and policy-makers, of the positions and activities of the European pharmaceutical industry as well as EFPIA Japan. The committee holds press conferences, issues press releases and organizes media seminars in order to ensure that the appropriate information is shared with the media, and ultimately with the relevant stakeholders.