The National Healthcare Security Administration (NHSA) has released the “Draft Technical Guidelines for the Preparation of Biosimilar Drug Labels” along with several other documents to guide the construction of the long-term care insurance (LTCI) system in China. The “Interim Measures” will come into effect on May 1, 2024, and aim to provide detailed technical requirements for the compilation of biosimilar drug labels, offering reference for medical professionals and patients in terms of medication choices, safety monitoring, and risk control .
Since 2015, China has introduced multiple guidelines on biosimilar drugs, including the “Interim Technical Guidelines for the Research and Evaluation of Biosimilar Drugs,” “Technical Guidelines for the Evaluation of Biosimilarity and Extrapolation of Indications,” “Guidelines for the Naming of Biological Products,” and “Q&A on Issues Related to the Research and Development of Biosimilar Drugs.” These documents have provided principle-based suggestions on the writing of biosimilar drug labels, but detailed standards have not yet been formalized.
The new guidelines propose that the national healthcare security administrative department will be responsible for the establishment and management of the national long-term care insurance expert database. Provincial and local healthcare security administrative departments may also establish and manage their own expert databases, with encouragement for provincial departments to unify the establishment and management of local expert databases. When healthcare security departments at all levels carry out policy research, consultation, project commissioning, research, and training in the field of long-term care insurance, they should, in principle, select experts from their own or higher-level expert databases.
The guidelines mainly regulate the conditions and procedures for inclusion in the database, the rights and obligations of experts, and the management and maintenance of the expert database. They clarify the conditions for inclusion, defining the national database experts as core experts and consulting experts, and stipulate the basic conditions that these two categories of experts should possess. The guidelines also clarify the rights and responsibilities of experts, determining the obligations that experts should fulfill when included in the database, such as carrying out commissioned research and policy consultation, actively promoting the policy of the long-term care insurance system, and promoting the construction of related disciplines, with an emphasis on work, confidentiality, and integrity disciplines. Lastly, the guidelines establish a dynamic management mechanism for the expert database, proposing measures for entry, exit, and assessment, and detailing the management responsibilities of healthcare security administrative departments, the rules for expelling the expert database, and the term of inclusion in the database.- Flcube.com
