The new drug registration process in Vietnam was introduced by DAV (Drug Administration Vietnam) in October 2022 with the issuance of Circular 08/2022/TT-BYT by the Ministry of Health. The new process aims to streamline the registration process and make it more efficient.
The main changes under the new process include:
A simplified application dossier format
A shorter review period
A new online registration system
The simplified application dossier format includes a number of new documents that are not required under the previous process. These documents include:
A Certificate of Pharmaceutical Product (CPP) issued by the EMA or any SRA (Stringent Regulatory Authority)
Legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements
The shorter review period under the new process is 60 days for domestic drugs and 90 days for imported drugs. This is a significant reduction from the previous review period of 180 days for domestic drugs and 270 days for imported drugs.
The new online registration system allows applicants to submit their applications and track the progress of their applications online. This is a more convenient and efficient way to register drugs in Vietnam.
The new drug registration process in Vietnam is a welcome change that will make it easier and faster for companies to register their drugs in the country. The new process is also more transparent and efficient, which will benefit both companies and patients.
Here are the steps involved in the new drug registration process in Vietnam:
Review your product details and understand the regulatory requirements applicable to your product.
Compile and submit the application dossier.
Evaluate the application dossier.
Respond to queries and receive the product registration certificate.
The application dossier must include the following documents:
Product information sheet
Legal documents of the manufacturer
Other relevant documents
The application dossier must be submitted in Vietnamese. However, the CPP can be submitted in English.
The review period for the application dossier is 60 days for domestic drugs and 90 days for imported drugs.
If the application dossier is approved, the applicant will be issued a marketing registration certificate. The marketing registration certificate is valid for 5 years.
For more information on the new drug registration process in Vietnam, please visit the website of the Drug Administration of Vietnam (DAV).