Interpretation of the Policy Announcement on the Relevant Matters Concerning the Evaluation of the Quality and Efficacy of GenericDrugs
1 why should we insist on promoting consistency evaluation?
A: With the continuous advancement of medical technology, the drug review standards are constantly improving. The past drug review standards did not mandate that the generic drugs and the original drug quality and efficacy are consistent. Therefore, some drugs have a certain gap between the efficacy and the original drug. Improvements are improved. Carry out the conformity evaluation of generic drugs to ensure that the generic drugs are consistent with the original research drugs in terms of quality and efficacy. It can not only save medical expenses but also improve the quality of generic drugs and the overall development of the pharmaceutical industry. Level to ensure that public medication is safe and effective.
- What is the progress of the consistency evaluation work?
A: As of the end of November 2018, 112 varieties of evaluations have been completed, including 90 of the 289 basic drug-related varieties in the National Essential Drugs List (2012 Edition). These varieties include the evaluation of the varieties through the consistency evaluation, the original research into the reference preparation varieties, the change of specifications, the modification of the dosage form, and the modification of the prototype of the salt-based variety have passed the consistency evaluation of the variety.
3 how to further promote the evaluation of basic drug varieties?
A: The state encourages enterprises to actively carry out the evaluation of basic drug varieties. The drug supervision department will continue to issue catalogues that can exempt or simplify human bioequivalence test varieties, and have special situation variety evaluation requirements according to the specific conditions of basic drug varieties, further increase service guidance, and organize on-site for key varieties and key enterprises. Research and communication, help enterprises solve difficult problems, establish a green channel for compliance evaluation applications, and follow the trial. If a company encounters major technical problems in the course of research, it may communicate with the drug evaluation agency in accordance with the relevant provisions of the “Administrative Measures on Communication and Technology Review Communication and Communication”.
4 how to ensure that the evaluation criteria for consistency evaluation are not reduced?
A: The State Food and Drug Administration will adhere to the principle of consistency with the quality and efficacy of the original drug, and conduct technical review in accordance with the published guidelines for drug research and development, and urge enterprises to continuously improve pharmaceutical research and human bioequivalence. Quality of sexual research.
5 How to strengthen the supervision of the varieties through consistency assessment and avoid consistency evaluation as a “one-time evaluation”?
A: The drug regulatory authorities will strengthen the supervision of the varieties that have passed the consistency evaluation. The drugs that have passed the consistency evaluation will be included in the next national drug sampling inspection plan, and the relevant enterprises will be strengthened to supervise and inspect.
The State Food and Drug Administration is organizing the formulation of relevant regulations to regulate the change management of bulk pharmaceutical raw materials, pharmaceutical excipients and pharmaceutical packaging materials.
- The current conformity assessment cannot be completed in accordance with the time limit set by the “Opinions of the General Office of the State Council on the Evaluation of the Quality and Efficacy of Generic Drugs” (Guo Ban Fa  No. 8), and the reasons for the adjustment of the working time limit by the State Food and Drug Administration. What is it?
A: First, the consistency evaluation of basic drug varieties and the dynamic adjustment of the basic drug list are promoted. The National Essential Drugs List (2018 edition) was implemented on November 1, 2018. The old catalogues were greatly adjusted. The basic drug catalogue has established a dynamic adjustment mechanism. The varieties that have passed the consistency evaluation are preferentially included in the catalogue. The varieties that pass the consistency evaluation will gradually be transferred to the catalogue.