EFPIA Japan | A drug's journey

A drug's journey

Drug development, approval, manufacturing, and post-marketing

  • Development of a new drug involves a complicated process that requires a lot of time and enormous amounts of funding. In order to create one drug, you would need to evaluate approximately 700,000 candidates. Of them, just one reaches the patients. Here, we will share how a new drug begins its journey, from the research and development of candidate compounds, to a product, to the patients, and how we are involved with drugs once the physician prescribes a drug to patients. We will explain what pharmaceutical companies call “the lifecycle of a drug.”

    “The lifecycle of a drug.”click here

  • The various steps in this process are usually conducted by pharmaceutical companies alone. However, at times accomplishments are made through a cooperative effort with universities and medical institutions. In order for cooperative research with universities and medical institutions to steadily progress, and for new drugs to be created as a result, companies sometimes contribute by providing funding to the research. The types of funding provided are presented in the table below. Also, for certain items an example is illustrated and explained in each process within the “product lifecycle”.
  • The progress of each process within the “product lifecycle” is managed by adhering to various laws and self-regulations. We will explain the process of drug development that at times is considered complicated, to the manufacturing and distribution of new drugs, and related laws and regulations to adhere to. The following table shows one part of the product lifecycle chart.

    Product lifecycle and requirements overview

    Product lifecycle and requirements overview

Terminology: Product lifecycle and related laws

  • The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices
    A Law regulating matters related to the manufacturing, distribution, standards and screening, handling and advertising regulation and others for healthcare products, quasi-drugs, cosmetics and medical devices in Japan. In order to ensure the safe and swift provision of pharmaceuticals and medical devices, etc., necessary measures are taken including establishment of the obligation to notify package inserts, expansion of the range of certification of medical devices by Accredited Certification Bodies, and establishment of a conditional and a term-limited approval system for regenerative medical products. (Implementation date: November 25, 2015)
  • GLP:Good Laboratory Practice
    A standard for conducting non-clinical studies on the safety of drugs. It is a standard regarding animal studies in non-clinical studies, particularly regulated for toxicity studies.
  • CMC:Chemistry, Manufacturing and Control
    Information regarding Chemistry, Manufacturing and Control. It refers to the integrated concept of researches for drug substance process, drug development, and quality assessment, as well as works related to those researches. The pharmaceutical companies’ CMC includes a wide range of work from non-clinical studies, clinical studies to regulatory approval applications.
  • GCP:Good Clinical Practice
    A standards regarding the implementation of clinical trial for pharmaceutical products.
  • ICH:International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    A project that brings together regulatory authorities in Europe, Japan and the United States. The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
  • GMP:Good Manufacturing Practice
    A ministry ordinance related to standards for the manufacturing management and quality management of pharmaceutical products and quasi-drugs. It refers to the standard for the manufacturing management and quality management at manufacturing facilities of pharmaceutical products and others.
  • PV:Pharmacovigilance
    Activities related to the safety monitoring of pharmaceutical products. It refers to the careful monitoring and continuous surveillance of the safety of an approved product during its life on the market.
  • GQP:Good Quality Practice
    A standard on the quality management of pharmaceutical products and others.
  • GDP:Good Distribution Practice
    A standard on pharmaceutical product distribution.
  • GPSP:Good Post-marketing Study Practice
    A standard on the implementation of the pharmaceutical products’ post-marketing surveillance and study.
  • GVP:Good Vigilance Practice
    A standard on the safety management of pharmaceutical products and others after manufacturing and distribution.