ArticleBritish journal of clinical pharmacology2011
Additional safety risk to exceptionally approved drugs in Europe?
Article in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed.
- Direct healthcare professional communications: A quantitative assessment study.Pharmacology research & perspectives · 2021Observational
- Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis.Health economics review · 2021Article
- Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities.Clinical pharmacology and therapeutics · 2020Article
- Safe Drugs Versus Innovative Drugs (Can We Have Both?).Advanced pharmaceutical bulletin · 2020Article
- The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.PLoS medicine · 2019Article
- The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach.Frontiers in medicine · 2019Review
- Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties.Orphanet journal of rare diseases · 2018Article
- Registries supporting new drug applications.Pharmacoepidemiology and drug safety · 2017Article
- Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.BMJ (Clinical research ed.) · 2017Article
- Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.British journal of clinical pharmacology · 2015Article
- Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.British journal of clinical pharmacology · 2015Article
- Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study.BMJ open · 2014Article
- How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009.Open medicine : a peer-reviewed, independent, open-access journal · 2014Article
- Article
- A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.British journal of clinical pharmacology · 2013Review
- Article
- Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.Drug safety · 2011Article
Corrections and comments
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Authors and funding
6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
aimsRegulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues.
methodsA retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates.
resultsIn total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P= 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P= 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate.
conclusionThe EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval.
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