Abstract：
:In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regulatory agency capabilities together with duplication in non-value added national regulatory requirements, particularly in low- and middle-income countries (LMICs), can slow down regulatory approvals and therefore impede patient access to new medicines. These gaps exist despite the achievements in both regulatory convergence and harmonization of technical requirements by bodies such as the International Conference on Harmonization (ICH). There is a pressing need to strengthen regulatory review systems in emerging market economies as highlighted by the World Health Organization (WHO). These diverse challenges may seem overwhelming to individual national regulators, in part because of the sheer number of initiatives by multiple stakeholders, combined with a lack of information on concise practical actionable measures that can have a positive impact on review efficiency. This commentary presents 10 pillars that we believe represent the key hallmarks of strong regulatory review systems. Leveraging our internal company expertise at the global, regional, and country level across our entire product portfolio (both innovative and generic), we selected features proven to work in leading regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which are also relevant for other regulatory authorities, especially in LMICs.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
O'Brien J,Lumsden RS,Diehl DH,Macdonald JCdoi
10.1007/s43441-019-00055-9subject
Has Abstractpub_date
2020-03-01 00:00:00pages
283-292issue
2eissn
2168-4790issn
2168-4804pii
10.1007/s43441-019-00055-9journal_volume
54pub_type
杂志文章abstract：BACKGROUND:Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investin...
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journal_title：Therapeutic innovation & regulatory science
pub_type： 社论
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abstract：:When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new dr...
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journal_title：Therapeutic innovation & regulatory science
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