Question. “I am a Regulatory Affairs Specialist for a company in Massachusetts. We provide regulatory, quality, and clinical services to the biomedical industry.
We understand that all labeling and instructions for use for medical devices in Japan are required to be written in the Japanese language.
We are now trying to understand exactly what the other labeling requirements are. With 5 levels of legislation in Japan ranging from the PAL to Ministry Ordinances to administrative notices released by the MHLW, it seems impossible to find the exact piece of legislation that details these requirements. Would you be able to help me find it?
Answer. I can understand your frustration. This is kind of like the FBI, CIA, ATF, and other U.S. government agencies not working together before 9-11. I will try to help you as best I can.
The Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law (PAL). The original PAL dates back to 1943, with subsequent revisions in 1948, 1960, and 1979. However, the basic purpose of the law has remained the same: to ensure the safety, efficacy, and quality of medical products in Japan.
The latest revisions to the PAL are meant to address the enhancements in the development and safety of new medical products in the 21st century. According to the Ministry of Health, Labor and Welfare (MHLW), the revised PAL is intended to strengthen the safety measures related to medical devices, enhance government regulations with respect to the application of biotechnology and genome technology in developing medical products, and fortify post marketing safety measures (and the review system for approval and license) while taking international conformity into account.
The revised PAL is a done deal, but MHLW has yet to finalize many of the regulation-level details. Thus, many of the proposed changes are currently in high-level “Parliamentary Act” form. The ministry will announce regulation-level details gradually over the next several years through what they call enabling notifications.
Photo Below: Label requirements can be confusing.
Reorganization of Authoritative Bodies in the MHLW
In addition to the Japanese PAL revisions, the MHLW is also reorganizing the structure of the authoritative bodies in the ministry as part of the government’s reform efforts. The MHLW signed a bill establishing an independent administrative institution that will merge the Organization for Pharmaceutical Safety and Research (OPSR, also known as Kiko), the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) — which is under the auspices of the National Institute of Health Sciences — and the Japan Association for the Advancement of Medical Equipment (JAAME).
Prior to their unification, OPSR/Kiko and the PMDEC operated as separate government entities. OPSR/Kiko was responsible for reviewing safety and efficacy of pharmaceuticals, and the PMDEC had similar responsibilities for medical devices. JAAME was an independent association working in conjunction with MHLW, focusing on “me-too,” or derivative medical devices.
The new institution is referred to as the Comprehensive Organization for Medicines and Medical Equipments. Its primary mission will be to ensure the quality, safety, and efficacy of medicines and medical equipment in Japan. The organization will also be responsible for improving national health by addressing health problems caused by adverse drug reactions (ADRs) and infections from biological products and promoting development in pharmaceutical technology through product reviews and fundamental research.
As for the changes in MHLW for labeling:
New Guidelines for Medical Devices Packaging
The MHLW has issued new guidelines for medical device packaging — The Guideline of Package Insert for Medical Devices — which aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent potential adverse events. Companies with already approved device products must revise their product inserts to comply with the new regulations. Basic package inserts should be in compliance with the information provided on the shonin (approval) application and should include the following:
Date of publication and most recent revision; Shonin number; Classification and generic name; Trade name; Warnings; Contraindications; Shape and structure; Performance indication for use, efficacy and/or effectiveness; Instructions for use and/or handling; Cautions; Principle of operation; Clinical records; Method and duration of preservation; Handling instructions; Maintenance instructions; Condition for shonin; Packaging information; Major reference papers and where they might be obtained; and Name and address of manufacturer and/or importer.
The name of the medical device, manufacturer’s serial number or lot number, and manufacturing code will be required to be affixed to the device or its immediate packaging. This is in addition to the direct presentation of the name of the distributor and expiration date on the medical equipment that is currently required.
If this is not the information you were looking for, I suggest you contact the “Japan Pharmaceutical Manufacturers Association” (JPMA).
Notable & Quotable: “A word to the wise ain’t necessary – it’s the stupid ones that need the advice.” — Bill Cosby