Japanese PAL Revision: Biological Products

As part of the extensive Pharmaceutical Affairs Law (PAL) revisions in Japan, the Japanese government has instituted changes to their current regulations in order to consolidate safety measures for biological products. The regulatory changes for biological products were introduced in July 2003.

Under the revised PAL, biological products are defined as “products including ingredients derived from human or biological (excluding plants) source materials (such as cell, tissue, blood, etc.), which should be subject to particular attention from the public health point of view.” Examples of these products include: blood products/plasma derivatives, vaccines, recombinant proteins (cell cultured), cellular/tissue-based products, and gene therapy vectors. Major characteristics of biological products include:

  1. The inability to rule out potential risk from infectious agents derived from source materials.
  2. The safety of individual products is dependent upon the donor profile of unspecified persons/animals from which the source materials are collected.
  3. Limited capabilities of inactivating infectious agents in a product while still maintaining the product’s integrity and function.

Among other changes, the revisions in the Japanese PAL include a classification system for biological products based on risk factors and the laying down of duties and roles for manufacturers, health professionals, and the government agencies involved with biological products. A revised approval and licensing system has been put in place in order to enhance introduction and safety of products and to bolster post-marketing safety measures. The revisions also include a system to retain records for traceability of infections as well as an Infection Relief Fund designed to provide assistance to persons infected by biological products. Contributions to the fund will be made by manufacturers. Victims will be compensated based on the severity of infection. The Infection Relief Fund is expected to be operational by April 2004.