ASEAN CTD application Vietnam Pharmaceutical Japan cosmetics
✔ We support the registration of Pharmaceuticals, APIs, cosmetic and medical devices.
✔ We will show the processes from the preparation of dossier (ASEAN CTD) to registration of products following ASEAN regulations.
✔ We prepare/review the application dossiers in ASEAN CTD form （PART Ⅰ,Ⅱ,Ⅲ and,Ⅳ in English (partly in local language）.
✔ We totally support from the preparation of dossiers, application and inquiries from the authority.
✔ We totally support from the preparation of dossiers, application and inquiries from the authority.
✔ We pay maximum efforts to register the products as soon as possible.
✔ In case of Vietnam, we also support trademark registration, patent research and registration, and related services.
✔ We provide service contents and fees on your request.
Please refer to Business for detail.
▸ To contribute to the business expansion of clients to ASEAN countries from Pharmaceutical regulation side
▸ To work as a part of Pharmaceutical affairs division of the clients
▸ To contribute to efficient and effective operation of clients by supporting to prepare ACTD and registration of products
▸ ASEAN is going to standardize the administrative procedures as one unified area from application to disposal
▸ ASEAN follows international standards such as ICH, GMP, PIC/s and set up ASEAN CTD (ACTD) and ACTR
▸ ASEAN countries aim at mutual recognition in Pharmaceutical field in the future
▸ The trend will expand rapidly not only for Pharmaceuticals but to medical devices, cosmetics and supplements
▸ Obtain the product License as a first priority
▸ Introduce your products to ASEAN Market ahead of competitors
▸ Expand business to ASEAN countries starting from one selected country
▸ Expand the approval license to other countries
▸ Key Words (3Ss),
✓ Strategy
✓ Speed
✓ tandardization
On September 5, 2022, Circular No. 08/2022/tt-byt was announced and will be implemented from October 20, 2022. Other notices related to pharmaceutical applications have also been issued. The main points of these notifications are as follows:
1. The requirements for CPP (Certificate of Pharmaceutical Product) have been significantly relaxed. Since Japan is a reference country , therefore, so-called 2CPP problem is now gone and can be made using only Japanese CPP. Also, CPPs that follow the WHO template are accepted.
2. Some regulations regarding labeling have been revised.
3. The number of active pharmaceutical ingredients (APIs) requiring BA/BE testing has increased from 12 to 26.
4. Referrals for information during the application review process are limited to three times.
5. A list of approximately 8,900 items has been released, and the license renewal for items that expire from January 1, 2023, to December 31, 2024, has been approved by the parliament.
If you have any questions, please contact us.