On this basis, achieve bioequivalence with the reference listed drug.
The second major change occurred in 2015. The “Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices” redefined generic drugs, clearly adjusting generic drugs from “drugs that imitate existing national standards” to “drugs that are consistent in quality and efficacy with the original research drugs.”
Source: DXY, compiled by itself based on public information
Since then, generic drugs in China need to be “consistent in efficacy” with the original research drugs, and by designating the reference listed drug of generic drugs as the original research drug, China’s generic drug approval has been aligned with international standards.
In order to address the issue of drug accessibility and promote market competition, the United States was the first in the world (1984) to pass the “Drug Price Competition and Patent Term Restoration Act,” which established a more simplified approval process for generic drugs, allowing generic drug companies to submit simplified new drug applications (ANDA), changing the requirement for generic drugs to undergo complete Phase I, II, and III clinical trials to clinical bioequivalence trials.
1984 US “Drug Price Competition and Patent Term Restoration Act”
Generally, generic drug manufacturers need to conduct double-blind randomized trials on a prescribed number of subjects, and pharmaceutical equivalence + bioequivalence is considered clinically equivalent in efficacy. The difference is that the United States reduced the requirements for clinical trials without lowering the standards, replacing complete clinical trials with bioavailability tests and bioequivalence tests.
China has raised the requirements on this basis, i.e., “generic drugs must be consistent in quality and efficacy with the original research drugs.”
This regulation is to avoid generic drugs being too much worse than the original research drugs in efficacy: a deviation of within 20% in bioavailability is allowed for generic drugs. Before 2015, generic drugs only needed to be compared with drugs that had already been marketed, then it was possible for generic drug No. 1 to imitate the original research drug, with 80% efficacy; generic drug No. 2 to imitate No. 1, with efficacy dropping directly to 64%.
Regarding the consistency evaluation of generic drug quality and efficacy, Hu Xin, chief pharmacist of the Department of Pharmacy at Beijing Hospital, said: “In terms of the concept and standards of generic drugs, I think we are superior to the United States and the United Kingdom. In addition, cross-comparisons of the same batch of subjects can eliminate many interference factors.”
“Clinicians often point out that drugs that have not passed RCT studies have questionable efficacy and safety. But in fact, the current consistency evaluation studies, whether pharmaceutical or in vivo studies, are beyond international standards. Taking azithromycin as an example, the raw material quality control of domestic drugs is higher, and there is less interference from impurities.”
In February of this year, the National Healthcare Security Administration issued a “Real-World Study of the Quality of Drugs Collected in Centralized Procurement”: Two well-known top-tier hospitals in China conducted a clinical real-world study on metformin selected in centralized procurement, and the results showed that the efficacy of the selected generic drugs was equivalent to that of the original research drugs.
Shanghai Proposal: Feedback from clinicians should be collected
According to data released by the National Medical Products Administration, currently, more than 200,000 batches of various drugs are sampled and tested nationwide each year, and the overall pass rate has remained stable at over 99% for many years. “Since the start of centralized procurement, more than 8,000 inspections have been accepted so far, and the quality has been fully qualified.” A head of a well-known pharmaceutical company said.
But just sampling and testing seems not enough, since the public has doubts and doctors have reflected that there are differences in the quality of drugs, information from the clinical front line needs to be taken seriously.
Drug safety and efficacy are matters of life, and stricter and more complete systems are the guarantee of life and health.
In unison, the Shanghai Municipal Committee of the Revolutionary Committee of the Chinese Kuomintang’s “Proposal on Ensuring Patient Medication Safety and Continuity under the Background of Centralized Drug Procurement” and Luo Wenjie, Vice Chairman of the Baoshan District CPPCC and Executive Vice President of the Fudan University Affiliated Zhongshan Hospital Wusong Hospital, “Proposal on Strengthening the Consistency Evaluation of Drugs with Volume-Based Procurement to Make Patients’ Medication More Assured”, both put forward suggestions on the consistency evaluation and quality supervision of drugs under the background of centralized procurement.
Source: Shanghai Revolutionary Committee of the Chinese Kuomintang, Shanghai CPPCC
Among them, several points of concern are, first, relaxing the restrictions of hospitals on non-volume-based drugs, so that patients have drugs to choose from.
Second, strictly controlling the entire drug quality supervision system, for drugs that have obtained consistency certification, after entering centralized procurement, regularly or irregularly conduct drug testing on pharmaceutical factories, sampling regularly from terminals such as hospital windows and retail pharmacies, ensuring that the sampled drugs are exactly the same as the various efficacy of the consistency certification process.
Third, fully publicize the consistency test results, not limited to simple catalog listings, and remove varieties that do not meet regulatory requirements in a timely manner.
The fourth is to establish a unified feedback platform to collect clinicians’ opinions on the efficacy of drugs used in centralized procurement and provide timely feedback. (Planning: Yun Ye | Supervisor: islay | Image source: Dongfang.com )
Regarding the quality of drugs in centralized procurement, DXY experts initiated a vote and discussion, and hundreds of station friends have participated.
There are also colleagues from different departments who have shared the efficacy of the drugs they use in centralized procurement in the comment area, etc.
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