CFDA has recently announced new classification guidance for drug product application. Under this new guidance, drug product with modified dosage regimen, dosage forms etc. (second generation products) are defined as new drugs. Comparing with first generation NCE based drug products, these second generation tend to have less adverse effect, longer effective time and better patient compliance. Although Chinese companies have launched quite few NCE based drug products domestically no NDA product has gained approval from FDA. Developing products with modified dosage regimen, dosage forms etc. could be an alternative way for innovative drug products to be recognized internationally because these types of product development will have less financial requirement, higher success rate and shorter development time. Using solid oral modified release products as examples, this article has reviewed a variety of modified release technologies and their application in product development. Sales data are used to show the importance of these products. It has also indicated different aspects and considerations to develop modified release products.

new formulations  /  new drug products  /  modified release technologies  /  new drug category 2