Food and drug safety ministry issues three product development guides for small firms

The food and drug safety ministry said Wednesday it has published three guides laying out the documents and regulatory requirements needed at each stage of medical product development, aimed at small companies and researchers who lack development experience and infrastructure.

The guides were issued by the National Institute of Food and Drug Safety Evaluation, part of the ministry, and cover pharmaceuticals, medical devices and clinical statistics. They were produced as part of the ministry's 50 Food and Drug Safety Tasks, a program intended to ease everyday inconvenience for the public, support vulnerable groups and build a base for new industries.

The first volume sets out the basic concepts and test content for each non-clinical trial category in pharmaceuticals and biologics, along with the non-clinical and quality data required at each clinical stage. The second covers the classification of medical device items and grades and the performance and safety testing needed to prepare technical documents. The third addresses statistical considerations and examples at the clinical trial planning stage, including statistical preparations for small companies and researchers.

The guides also compare regulatory support programs, including pre-consultation for innovative products and a telephone hotline, setting out each program's outline, application procedure and the scope of who and what can be consulted.

The ministry said it expects the guides to raise small companies' and researchers' understanding of regulations and cut trial and error during development, shortening the time it takes to bring a product to market. It added that it will continue providing regulatory information to help innovative products reach the market quickly and expand treatment options for patients.

The guides are available on the ministry's website under the legislative information section.