Regulatory Approvals – Japan
Japan has a high reliance on the import of food, with the food self-sufficiency of Japan gradually decreasing to 37% in 2018. This makes Japan a very attractive market for genetically modified (GM) or genetically edited crop.
To obtain regulatory approval for placing GM crop on the Japanese market, complete safety assessments under the regulations for food (food sanitation law), feed (feed safety law) and environment (Cartagena law) are required. Developers of GM crop seeds are responsible for obtaining the regulatory approval prior to import of the GM crop into Japan.
Key challenges for GM seed developers are:
- Understanding Japanese regulation
- Data strategy development
- Dossier writing
- Liaising with regulatory authorities.
Next to GM crop, more and more seed developers are moving towards genome editing, a state of the art technology applied in food, feed and agriculture.
The greatest advantage of the genome editing is the ability to delete, insert or substitute specific genes to efficiently create varieties with desired characteristics beneficial both for farmers and consumers. This is a significant time saver compared to waiting for the desired mutation to occur or repeating multiple rounds of crosses and selections.
In Japan, the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Agriculture, Forestry and Fisheries (MAFF) are in charge of the notifications for genome edited organisms.
SCC offers support with all aspects of the submission and approval process for GM crop. For Japan’s unique requirement for in-country field trial (stage-3 trial), SCC liaises with local institutes (CRO) able to conduct in-country field trials for GM crop. We coordinate and monitor these trials on your behalf.
We help companies by providing guidance and follow-up with the respective authorities on the minimum data requirements for notifications.
We have more than 10 years' experience in biotech regulation and rely on a strong and broad network of key stakeholders in and outside Japan.
Our services for genetically modified crop include:
- Providing advice on data requirements for food, feed and environmental safety assessments
- Coordinating and monitoring stage-3 field trials
- Preparing and submitting application dossiers
- Coordinating and communicating with the respective authorities, as well as preparing response letters to the authorities and technical committees
Our services for genome edited crop are:
- Offering guidance on data requirements for notification to MHLW and MAFF
- Communicating with the respective authorities, including preparation of response letters to regulatory authorities and technical committees