Japanese legislators will soon make major changes to Japan’s Pharmaceutical Affairs Law (PAL), which has governed all drugs and medical devices sold in Japan since 1960. Under two separate bills being considered by the diet, cellular and gene therapy products will have their own classification and approval system, standalone medical device software will be independently regulated and third party certification of medical devices will be expanded and modified.
Currently, cellular and gene therapy products such as skin grafts can be classified as either a medical device or a drug in Japan. Under the proposed system, these products will be classified in a new category with new regulations for clinical trials and approvals. Clinical trial length is likely to be shortened, and products will enter the market on a conditional basis before they receive final approval. The safety of all cellular therapy products must be confirmed before they enter the market, but monitoring of efficacy results will continue even after products are on the market. In addition, patients treated with cellular and gene therapy products may have to enroll in a national registry for monitoring purposes.
A second major change to PAL would involve revisions to IT medical devices. Currently, medical devices with IT components — such as MRI imaging equipment — are regulated as a combination product of both hardware and software. Under the new rules, software would be independently regulated as a stand alone product. Due to the complex nature of drafting new regulations, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) would likely use as guidance the standards established by the International Medical Device Regulators Forum.
Finally, third party certification of medical devices will likely be expanded and modified in the PAL revision. Currently, third party certification is allowed only for low risk Class II medical devices like digestive catheters and ultrasound diagnostic equipment. In the future, medium risk Class III devices such as artificial bone tissue may also undergo certification by approved third parties, rather than the PMDA. However, oversight of third parties will be strengthened, and inspectors will need to submit more quality management system (QMS) information to PMDA.
QMS inspections will also take place according to the product group, rather than according to individual products. For example, the PDMA might require only one QMS inspection for the product group “artificial heart-lung machine.” Currently, the certification of such a machine requires at least three separate inspections for the separate products that make up the machine. Regulators have not yet devised the list of product groups, but factors taken into account for grouping would include the usage method, the manufacturing process and the risk of the device.
It is not certain when final revision of PAL will take place, but Japan’s diet has already passed one act that would be incorporated into the final revision.