Japan’s new Pharmaceutical Affairs Law (PAL), effective as of April 1, 2005, outlines the new post-marketing safety measures, also known as Good Vigilance Practice (GVP). This regulation clarifies the responsibilities of distributors of medical devices, drugs, quasi-drugs, and cosmetic products. All Marketing Authorization Holders (MAHs) in Japan must comply with the GVP requirements in order to obtain an MAH license.
In the old PAL, Good Post-Marketing Surveillance Practice (GPMSP) was required. With the new PAL, GPMSP was divided into Good Post-Marketing Study Practice (GPSP) and Good Vigilance Practice (GVP). GPSP, which is not required but highly recommended, primarily focuses on collecting information regarding re-examination and re-evaluation of medical products. GVP, which is required to receive an MAH license, primarily focuses on adverse events and counter-safety measures.
Foreign companies must be aware that there are different GVP requirements depending on the type of drug or device classification. There are different guidelines for the responsibilities of the post-marketing safety controller, requirements for Standard Operating Procedures (SOPs), requirements for the post-marketing safety information that must be collected, and educational training. Also, it is possible to outsource some but not all, GVP responsibilities to another organization. GVP work that may be outsourced includes collecting information on the quality, efficacy and safety of the products, analyzing data on safety control information, conducting necessary counter-safety measures, and maintaining all information related to safety control.
In addition, the GVP guidelines require ALL records to be archived. The timeline for maintaining records is 10 years for drugs and medical devices derived from biological source materials, 30 years for designated drugs and medical devices derived from biological source materials, 15 years for Class III Highly Controlled Medical Devices other than designated drugs and medical devices derived from biological source materials, and 5 years for self-assessment and educational training records. The Ministry of Health, Labor and Welfare (MHLW) hopes this new regulation will improve the countermeasures for post-marketing safety according to the international harmonization process.