Japan is planning to change some of its quality-related regulations.
First is post-approval change management, a process already started on March 9, 2018. This is a system raised through ICH Q12 discussion that if you consult with the relevant authority and agree on a protocol and foreseen results using a post-approval change management protocol, you can implement the change, prior approval change, or notification of change, by getting the authority confirmation. This system enhancement will become effective August 1, 2021.
Second is the changes in GMP. Revision of GMP ordinance (JGMP) will become effective August 2021 with 3 major changes.
- Stability testing managing procedures must be documented as a site (manufacturer) SOP.
- Quality-related outsourced work must be adequately controlled. The definition of work seems to include not only GMP work but other operations, in which controls are applied for example, to a supplier of HPLC equipment and a work clothes laundry company. You would need to qualify and monitor the outsourced company’s performance.
- DI. Japanese GMP will require data integrity for paper records. Electronic records will be discussed in Q&A section of JGMP.
The GMP ordinance and Q&A of JGMP are expected to be released in March 2021, with a draft in December 2020.