Science & Tech · Science & Environment · 1 hr ago
South Korea publishes regulatory guidance for advanced biopharmaceuticals
South Korea’s food and drug regulator has published guidance for companies developing advanced biopharmaceuticals.
These include cell therapies and gene therapies.
The materials are intended for companies preparing clinical trials or applying for product approval.
They explain review standards, the documents companies must submit, and how to prepare those documents.
The guidance also describes regulatory support information for companies working through the process.
It is available on the regulator’s Drug Safety Country website.
South Korea’s Ministry of Food and Drug Safety published regulatory training content for companies developing advanced biopharmaceuticals.
The materials are intended for companies preparing clinical trials and product approval applications.
They cover review standards, required submission materials, guidance on preparing review documents and regulatory support information.
The content was made available on the Ministry’s Drug Safety Korea website on Oct. 19.
- Who
- South Korea’s Ministry of Food and Drug Safety.
- What
- It published regulatory training content for advanced biopharmaceuticals.
- When
- Oct. 19, 2026.
- Where
- The Ministry’s Drug Safety Korea website.
- Why
- To support companies preparing clinical trials and product approval applications.
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- Publisher
- South Korea’s Ministry of Food and Drug Safety
- Publication date
- Oct. 19, 2026
- Website
- Drug Safety Korea
- Coverage
- Review standards, submission materials, document preparation and regulatory support information