On May 14, the State Drug Administration issued the "Notice on Strengthening the On-site Inspection of Chemical Gene Injection Injection Application (No. 20 of 2018)" (hereinafter referred to as the "Announcement").
The "Announcement" shows that from the date of publication of the announcement, the State Drug Administration will increase the inspection of chemical generic injections that have been accepted by the provincial drug regulatory authorities and are being reviewed and approved by the State Drug Administration. The State Drug Administration Center of the State Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center), on the basis of rigorous review, puts on-site inspection requirements according to the needs of the review, and the Food and Drug Inspection and Inspection Center of the State Food and Drug Administration ( The following is referred to as the verification center).
These conditions require on-site inspection:
1. The prescription, process, packaging materials and production equipment of injections have changed. It belongs to the category III change as stipulated in the Technical Guidelines for the Research of Chemical Substance Change (1) and the Technical Guidelines for the Study of Processed Chemical Production Changes. Or a major change in the situation.
2. The production location (production line) of domestically produced preparations has changed.
3. For the first time, the chemical injection dosage form has been declared, and other varieties have not been produced in the corresponding production line.
4. The review process finds that the authenticity is suspected and needs to be verified.
5. Receive complaints about authenticity and reliability issues and need to verify the clues.
The key points of the inspection include:
1. The registered applicant's overall implementation of the quality management standard of pharmaceutical production and the sterility assurance ability of the declared varieties.
2. The dynamic production batch status at the time of product declaration, including the consistency and authenticity of the production batch and other materials.
3. If necessary, the verification center may require the registered applicant to arrange dynamic production and sampling inspection during the inspection.
According to the "Announcement", if the registered applicant finds that the application content of the relevant chemical generic injection preparation is untrue or incomplete, he may apply for withdrawal before the inspection center informs the on-site inspection. The application for withdrawal will no longer be accepted after the on-site inspection. If the on-site inspection finds that there is a problem of authenticity or even falsification, it will be seriously investigated according to law.
It is foreseeable that the examination and approval of chemical generic injections will be more stringent in the future, and the safety and effectiveness of drugs will be further guaranteed.
Injections are pharmaceutical dosage forms that are directly injected into the human body and are highly risky. On March 13 this year, the "Guidelines for the Research and Development of Drug Injections" issued in China was clearly defined, and strict supervision of the development of injections. Oral preparations can meet the clinical needs, and it is not recommended to develop injections; intramuscular injection can meet the clinical needs, and it is not recommended to develop intravenous injections, intrathecal injections, etc.
With regard to the examination and approval of drug injections, the state has paid more attention to it in recent years. For example, in October 2017, China’s “Opinions on Deepening the Reform of Examination and Approval System Reform and Encouraging Innovation in Pharmaceutical Medical Devices” highlighted the strict examination and approval of drug injections and the re-evaluation of injections.
With the issuance of the "National Drug Administration" "Announcement" and the implementation of the on-site inspection, it is not an easy task for the drug injection generic drug to successfully pass the examination and approval review. It is necessary to "pass the five customs and six will" to strengthen Safety protection of drugs.