ArticlePharmacology research & perspectives2017
Make up a missed lesson-New policy to ensure the interchangeability of generic drugs in China.
Article in Pharmacology research & perspectives, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed.
- Effects of Generic Entry on Market Shares and Prices of Originator Drugs: Evidence from Chinese Pharmaceutical Market.PharmacoEconomics - open · 2025Article
- Influencing Factors of Generic Prescribing Behavior of Physicians: A Structural Equation Model Based on the Theory of Planned Behavior.Risk management and healthcare policy · 2024Article
- Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model.Frontiers in public health · 2023Article
- An empirical study of the impact of generic drug competition on drug market prices in China.Frontiers in public health · 2023Article
- Has the Volume-Based Drug Purchasing Approach Achieved Equilibrium among Various Stakeholders? Evidence from China.International journal of environmental research and public health · 2022Article
- Creating China's Biosimilar Drugs Regulatory System: A Calculated Approach.Frontiers in pharmacology · 2022Article
- Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China.Frontiers in pharmacology · 2022Article
- The Impact of the Consistency Evaluation Policy of Generic Drugs on R&D Investment Intensity of Pharmaceutical Companies-An Empirical Study Based on the Difference-in-Differences Model.Frontiers in public health · 2022Article
- Knowledge, perceptions and practices of pharmacists regarding generic substitution in China: a cross-sectional study.BMJ open · 2021Article
- The Trend of Targeted Therapies in Chinese Patients With Ankylosing Spondylitis: Results From a Real-Life Survey.Frontiers in pharmacology · 2021Article
- Impact of the Pilot Volume-Based Drug Purchasing Policy in China: Interrupted Time-Series Analysis with Controls.Frontiers in pharmacology · 2021Article
- Innovative highlights of clinical drug trial design.Translational research : the journal of laboratory and clinical medicine · 2020Review
- Interrupted time-series analysis of the impact of generic market entry of antineoplastic products in China.BMJ open · 2018Article
- Make up a missed lesson-New policy to ensure the interchangeability of generic drugs in China.Pharmacology research & perspectives · 2017Article
- Commentary: Combating Sale of Counterfeit and Falsified Medicines Online: A Losing Battle.Frontiers in pharmacology · 2017Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Generic drugs should be interchangeable with originators in terms of quality and efficacy. With relative lower prices, generic drugs are playing an important role in controlling health expenditures and ensuring access. However, the widespread understanding of "cheap price equals low quality" has a negative impact on the acceptance of generic drugs. In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs. It intends to make up a missed lesson in the regulation to be in line with internationally accepted practices. Generic drugs firms, depends on the availability of appropriate comparators, should conduct either comparative bioequivalence studies or full scale clinical trials. The re-evaluation will be implemented in a stepwise approach with the essential medicines covered in the first step. The policy could achieve several benefits by increasing confidence on the Chinese produced generic drugs, upgrading regulatory standards, streamlining the Chinese generic drug industry and creating a healthy competition market. Nevertheless, enormous challenges remain in enlarging the capacity to review applications, selecting appropriate comparators, ensuring the capacity of domestic clinical research sites, and achieving the acceptance of re-evaluated generic drugs.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.