Defending transparency at European drug regulator

BMJ ◽  
2020 ◽  
pp. m10
Author(s):  
Pierre Chirac
Keyword(s):  
Drug Regulator

Recent developments in China’s biopharmaceutical industry (2012-2017)

2019 ◽  
Vol 10 (3) ◽  
pp. 686-707
Author(s):  
Marcus Conlé
Keyword(s):  
Product Innovation ◽  
Academic Research ◽  
Domestic Market ◽  
Growth Strategy ◽  
Future Research ◽  
Biopharmaceutical Industry ◽  
Content Type ◽  
Drug Regulator ◽  
Recent Developments ◽  
Product Portfolios

Purpose The paper aims to take stock of China’s recent biopharmaceutical industry development by analyzing product innovation and changes in the firms’ product portfolios during the five-year period between 2012 and 2017. Design/methodology/approach The paper introduces a classification of biopharmaceutical products. By applying the classification to the product data of China’s drug regulator, the CFDA, it becomes possible to trace the developments within the sector by looking at changes in the number of firms within each subgroup and changes in the number of subgroups in which each firm is involved. The classification allows an evaluation of the latest product innovation achievements. Findings The paper demonstrates a mild shakeout of firms in the relatively long-existing domestic market segments, a trend toward more specialized product portfolios and an enduring prevalence of innovation strategies aimed at exploiting relatively unpopulated domestic market niches instead of pioneering entirely new products. Especially the capability of upgrading to second-generation protein therapeutics has become a key criterion for separating the wheat and the chaff in China’s domestic sector. The paper moreover points out the relevance of acquisitions as a corporate growth strategy. Research limitations/implications The research does not consider complementary indicators, product pipelines in particular. Future research should compare patterns across emerging economies. Originality/value The paper is unique in using the CFDA database for systematic academic research on (bio)pharmaceutical innovation and in introducing a biopharmaceutical product classification to trace innovative activities and changes in corporate product portfolios over time.

Trial participants call for drug regulator to ensure study results are published

BMJ ◽  
2013 ◽  
Vol 346 (jan18 1) ◽  
pp. f382-f382
Author(s):  
Z. Kmietowicz
Keyword(s):  
Study Results ◽  
Drug Regulator ◽  
Trial Participants

scholarly journals Europe’s drug regulator opens vaults of clinical-trials data

Nature ◽  
2016 ◽  
Vol 538 (7626) ◽  
pp. 440-440 ◽  
Author(s):  
Alison Abbott
Keyword(s):  
Clinical Trials ◽  
Drug Regulator

scholarly journals Select committee angry over absence of drug regulator from session

BMJ ◽  
2005 ◽  
Vol 330 (7485) ◽  
pp. 214.4
Author(s):  
Lynn Eaton
Keyword(s):  
Select Committee ◽  
Drug Regulator
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