On February 19, 2014, "drug registration management measure (modified draft) in Chinese government public legal information network netting for advice. Compared with the current "method", modify the draft to encourage innovation, accelerate the drugs listed, etc., made some supplement and revision.

During new drug clinical trials may apply for the change

In recent years, the rise of drug research. During new drug clinical trials, and some of the applicants for prescription, process, production site and the certificate holder changes, but the current "method" is not corresponding to the above situation, makes the applicant cannot change corresponding contents, which in a certain extent, hampered the process of new drug research and development.

New terms, therefore, modify the draft regulations need to change the applicant during the period of new drugs in clinical trials, chemical medicines and biological products before Ⅲ period clinical trials need to adjust the production process, prescription, specifications as well as the change of production site, can apply for declare, in the form of complementary sex and provide relevant documents and research data; Change in the Chinese native medicine preparation process, specifications, according to the supplementary provisions of the Chinese traditional medicine registration management.

Time limit for generic drugs registration cancelled

The current "method" for generic drugs registration time constraints, over the years by enterprises. Its rules, the applicant in the drug patents within 2 years prior to the expiration of the period to apply for registration, in fact disguised extended the drug patent protection, delayed the generic drugs listed in our country.

Modify the draft with the patent law (2008 revision) cohesion, delete the outstanding patent medicines of generic drugs shall be two years before patents expire to declare related terms, to facilitate speed generics market, improve the accessibility of public administration in our country.

Have to accept the application for registrationis not restricted by drug monitoring period

In the current pharmaceutical research situation, companies at the same time period to declare a product at the same time is a very normal phenomenon. But the current terms of "method" of some actually restrict the normal competition between drug firms.

According to the current "method", need for drug safety, national food drug administration for approval of the production of new varieties to set up the monitoring period, to see the quality problem of the new drug and adverse drug reactions, etc. Monitoring period, has accepted but has not yet been approved for clinical trials of other applicants with varieties of application shall be returned.

For related items, modify the draft shall be deleted, and regulation: anyone who has accepted the application for registration of, can be in accordance with the drug registration application, examination and approval procedures and continue.

Generic drugs registration into the production site inspection

To ensure the authenticity of generics to declare materials, the current "method" regulation, generic drug clinical trials registered in production site inspection approval before implementation.

In fact, generic process prescription needs to adjust optimization according to the biological equivalent test results, finally determine the declaration process prescription; Site inspection and approval of clinical trials conducted before production between more resources, low efficiency, check the quality is not high, and with the technical evaluation, drug GMP inspection.

For this purpose, the revised draft of generic drugs to the production site inspection to complete drug clinical trials conducted before and after the technical evaluation, listing permits, to facilitate implementation technology review combined with production site inspection, improve the efficiency and quality of on-site inspection, also to reduce the burden of the applicant accept check many times.