November 2021 Pharmaceutical Regulations Update for Japan

Following the April 28, 2021 Japanese GMP ordinance outlined in a previous StabilityHub Newsletter, further rules and regulations contained in the Japanese Pharmaceutical and Medical Device Act were initiated on August 1, 2021, For the Japanese pharmaceutical industry, these measures include:

• Post-approval Change Management Protocols (PACMP) can be used for the manufacturing change system to address multiple changes to prior approval matters, as well as minor change notices. Once the PACMP is agreed between the authority (PMDA) and the company, relevant studies can be initiated. If the results obtained fall within the agreed specifications, they are reported for confirmation by the authorities. Upon their approval, the proposed changes can be initiated.
• The individual designated by the marketing holder as their “Pharmaceutical Officer” must be a pharmacist and must have the appropriate abilities to perform the responsibilities of the Pharmaceutical Officer as outlined in Japanese regulations.
• Except for the first shipment to healthcare facilities, the package insert is not physically required to be with the product.
• 4.5% of sales will be the penalty charged to the company if any false advertising claims are identified.
• Warehouses used exclusively to store materials (not shipment to the market) can be registered by simple procedures with no manufacturing permit necessary (June 2021).
• GS-1 type bar-codes on the packaging will become mandatory December 2022.

Numerous recalls based on GMP violations have raised concerns within the industry and have brought the authorities and industry representatives together to discuss every possible opportunity for improvement, resulting in further rules and measures to be issued in the future. Since some recalls have been due to very subtle defects of product, a new classification for this type of recall is under consideration, where, as appropriate, limited recalls involving the exchange of individual packages rather than the whole batch, could occur.

For manufacturing in Japan, two permits are required; one is the manufacturing license, effective for 5 years. The other is the product permit, effective for 2 years. As of this year (2021), a new regulation allows manufacturers to opt for a 3 year classification permit (e.g.; oral tablets, etc.) instead the 2 year product permit.

Whether a Japanese manufacturer or an international firm that manufactures in Japan, be sure to collaborate with your regulatory colleagues to stay compliant with the latest updates in Japan’s requirements.