ArticlePerspectives in clinical research2010
Drug lag and key regulatory barriers in the emerging markets.
Article in Perspectives in clinical research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
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- Bridging the new drug access gap between China and the United States and its related policies.Frontiers in pharmacology · 2023Article
- Delay in Vaccine Access in ASEAN Countries.International journal of environmental research and public health · 2022Article
- Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States.International journal of environmental research and public health · 2022Article
- The Health Impact Fund: making the case for engagement with pharmaceutical laboratories in Brazil, Russia, India, and China.Globalization and health · 2021Article
- Can the COVID-19 Pandemic Disrupt the Current Drug Development Practices?International journal of molecular sciences · 2021Review
- Bridging across patient subgroups in phase I oncology trials that incorporate animal data.Statistical methods in medical research · 2021Article
- Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice.Therapeutic innovation & regulatory science · 2021Article
- Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study.Frontiers in public health · 2021Article
- Advanced Medical Care Program for the Rapid Introduction of Healthcare Technologies to the National Health Insurance System in Japan.Clinical and translational science · 2020Article
- Challenges of international oncology trial collaboration-a call to action.British journal of cancer · 2019Review
- Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.Investigational new drugs · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There have been numerous investigations targeted at identifying whether a drug lag exists in the mature markets of the US, EU and Japan. This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical industry as a consequence of rapid economic and political development.The aims of this work are to ascertain whether a drug lag exists in the emerging markets and how it has changed over time from the 1960s to the 2000s. It will also highlight key regulatory barriers which may contribute to drug lag.The date of the marketing authorisation (MA) approval by the US Food and Drug Administration (FDA) was used as a reference point. A comparison against the company database regarding emerging market specific approval enabled the difference in time and thus the drug lag for that particular market to be calculated.This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; 'Western Approval', local clinical development (LCD), Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), pricing approval, document authentication and harmonisation.
Indexed as
Identifiers
21829782PMC3148610What OpenQuestion holds
Registered trials
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.