The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Pharmacological Research of Chemical Modified Drugs (draft proposal)”, which is now open for public comment for a period of one month. The aim of these guidelines is to clarify the clinical pharmacological characteristics and overall considerations of chemical modified drugs.
Definition and Advantages of Modified Drugs
A modified drug is defined as a drug that offers significant clinical advantages over known active pharmaceutical ingredients (API) by optimizing its structure, dosage form, prescription process, route of administration, and indications. Compared to innovative drugs with new targets and structures, modified drugs can leverage existing research data on known APIs, which can potentially reduce R&D investment and shorten development cycles. With the rapid advancement in pharmaceutical industry technology, modified drugs have become a popular direction in the current R&D landscape. Currently, there are no clear and systematic clinical pharmacology technical guidelines for these drugs either domestically or internationally.
Regulatory Comparisons and Focus on Clinical Advantage
In China, modified drugs are categorized as Category 2 chemical drugs, which are optimized based on known active ingredients and must demonstrate significant clinical advantages over pre-modification versions. China’s regulations and requirements for modified drugs are similar to the US 505 (b) (2) route, encompassing improvements in active ingredients, new dosage forms, new prescription processes, polypills, and new indications. However, the core of China’s modified drug applications lies in “having obvious clinical advantages,” whereas the FDA’s focus is on “whether unauthorized data from others has been used.” There are also differences in the types of drugs that can be filed through the 505 (b) (2) pathway in the US, such as prodrugs and deuterium band compounds, which in China are filed as innovative drugs.
Alignment with International Standards
The draft guidelines have been developed with reference to the technical requirements of regulatory agencies in developed countries in Europe, America, and Japan. They fully consider the current state of domestic R&D and drug development levels and are designed to be in alignment with ICH guidelines.-Fineline Info & Tech
