Some time ago, Hengrui Pharmaceuticals 's iodixanol application was approved for ANDA (generic drug launch) in the United States, which brought a long-lost excitement to the long-dormant generic drug industry and aroused public concern. Generic drug concerns.
Are “generic drugs” reliable? What does " generic drug consistency evaluation " mean?
Drugs on the market can be divided into innovative drugs and generic drugs . Innovative drugs (also called original drugs ) refer to original new drugs, which are usually drugs that have gone through layers of screening and rigorous clinical trials of thousands of compounds before they are approved for marketing. Original drugs require large investment, long cycle, and high risks, so they will enjoy patent protection for about 20 years, and the price during this period is often relatively expensive. Generic drugs, on the other hand, are the main source of interest from other pharmaceutical companies after the patent of the original drug expires. Drugs whose ingredients are replicated. Modern generic drugs originated from the "Hatch-Waxman Act", the "Drug Price Competition and Patent Protection Act" signed and passed by the U.S. Congress in September 1984, and has been officially implemented since November 1984.
Since there is no research and development cost for generic drugs, coupled with the influx of pharmaceutical companies, in terms of price, generic drugs will be much cheaper than original drugs. In some developing countries, the development of generic drugs is the basis for establishing a pharmaceutical industry system. It is also a rational choice when the economic level is not high and the disease burden is heavy. Compared with expensive original drugs, generic drugs not only reduce the pressure on medical insurance, but also reduce the pressure on medical insurance. It also reduces the pressure on people to see a doctor.
In recent years, China's generic drug industry has received great attention from governments at all levels and key support from national industrial policies. The country has successively introduced a number of policies to encourage the development and innovation of the generic drug industry. According to relevant statistics, In 2020, domestic pharmaceuticals In the market, generic drugs account for as high as 63%.
Although the price of generic drugs has been reduced, ordinary people still have concerns, such as: Are the quality and efficacy of generic drugs the same as those of the original drugs? ?
In order to closely monitor the quality of generic drugs, improve drug quality standards , and promote industrial upgrading, my country first proposed in the "Twelfth Five-Year Plan" released in 2012 to carry out consistency evaluation of generic drugs in phases and phases, and subsequently issued The policy clearly clarifies that generic drugs commonly used in clinical use and in the Essential Drug List are the main evaluation targets, and a specific evaluation timetable has been released.
On March 5, 2016, the "Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs" issued by the General Office of the State Council was officially announced, marking the comprehensive launch of the consistency evaluation of the quality and efficacy of generic drugs in my country. .
Generic drug consistency evaluation: refers to the quality consistency evaluation of generic drugs that have been approved for marketing in phases and in batches in accordance with the principle of consistent quality and efficacy with the original drug. Generic drugs that have passed the consistency evaluation can have the above logo printed on their packaging boxes.
Not long ago, the State Food and Drug Administration also issued a document explaining "What is the consistency evaluation of generic drugs". The State Food and Drug Administration pointed out that generic drugs can replace original drugs and play the same clinical role, which can reduce medical expenses, improve drug accessibility, and improve medical service levels.
The State Food and Drug Administration stated that in accordance with the requirements of relevant documents of the State Council, in the reform of the drug and medical device review and approval system, the state has listed improving the quality of generic drugs as one of the important reform goals. In the past few years, the drug regulatory department has ensured the smooth progress of the consistency evaluation of generic drugs by establishing a working mechanism, improving the review system, strictly evaluating standards, strengthening service guidance, and optimizing work processes.
According to the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" released on December 30, 2021, During the "13th Five-Year Plan" period, my country has solidly promoted the quality and efficacy consistency evaluation of generic drugs and announced the parameters. Compared with the 3963 product specifications in the preparation catalog, 964 applications for 278 varieties have passed consistency evaluation.
During the “14th Five-Year Plan” period, the quality and efficacy consistency evaluation of generic drugs will continue to be promoted. Continue to promote the consistency evaluation of oral solid preparations of generic chemical drugs, and steadily promote the consistency evaluation of generic injections of chemical drugs. Improve consistency evaluation policies and technical standards, update and improve the catalog of reference preparations, and promote the improvement of the quality of generic drugs. Continuously track and supervise the quality of generic drugs that pass consistency evaluation.
In fact, it may not be easy to make people completely trust generic drugs. For patients, whether it is a generic drug or an original drug, the luckiest thing is to find a drug suitable for their condition through formal channels!
Writing/editing: Xu Xiaolin
Reference sources: People's Daily Online, People's Daily, Science and Technology Daily and other public information
