The three main points of the latest "Management Measures for the Issuance of Biological Products"
On December 15th, the CFDA solicited opinions on the “Administrative Measures for the Issuance of Biological Products” (revised draft), and for the first time clarified the qualifications, duties and authorities of the “drug certification agency”. In addition, unlike the relatively short solicitation period, the deadline for comments is January 15, 2016.
“Batch issuance” proposed by the World Health Organization is one of the six regulatory functions of drug regulatory agencies in various countries to ensure the quality of vaccines (the other five are based on safety and effectiveness as evaluation criteria, approval procedures, post-marketing for adverse reactions, GLP management of product quality control, GMP inspection of production companies). Because biological products are biologically active, variability, heat sensitive, and susceptible to microbial contamination, they must be issued in batches to maximize their safety and effectiveness.
At the moment when the CFDA has repeatedly raised the quality of drug clinical trials and the quality of generic drugs, the release of this draft opinion may mean that biological products will become the next key regulatory object of CFDA.
It is not difficult to find out from the consultation draft that there are three main differences between the 2015 edition and the documents issued in June 2004:
First, the “drug verification agency” that first proposed “to undertake acceptance, data review, sample inspection, on-site verification, issuance, etc.” was appointed by CFDA;
Second, build a batch of biological products to issue a network, and clarify the responsibilities of the relevant agencies:
CFDA: Responsible for the designation of the batch issuing organization; more importantly, establish a unified batch issuance application system, and provide the applicant with information such as the batch issuance progress, inspection results and conclusions.
The Central Inspection Institute: responsible for formulating the assessment guidelines for batch issuing agencies, guiding, training and assessing the batch issuance work of other batch issuing agencies; at the same time, responsible for the daily operation and maintenance of the batch issuance system; evaluating and appraising the batch issuing agencies
The batch issuance agency: responsible for the specific work of the batch issuance, including acceptance, data review, sample inspection, on-site inspection, issuance, etc. At the same time, the batch issuance agency shall disclose the qualified and unqualified information of the batch of biological products to the public, as well as in this institution. The website or the application acceptance site publicly approves the application procedures, charging standards and basis, time limit and other information.
Drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government: responsible for organizing on-site sampling and batching of unqualified products for disposal and investigation.