During the past 10 years the centralized procedure has become the preferred and de facto only way to a European marketing authorization for innovative medicines. The European Medicines Agency (EMA) has been working on several initiatives for updating and improving the content and procedures of their scientific assessments. The historic decision of the United Kingdom (UK) to leave the European Union (EU) is expected to precipitate profound political, economic and legal changes, which must be expected to include the regulation of medicines. Brexit-induced changes in EMA’s regulatory procedures are not expected before negotiations between the UK and the EU are finalized (i.e., not before 2019). In light of the usual long time frame for the development of an innovative medicine, the proactive adaptation of the development strategy in advance of the expected changes of European regulators’ and possibly Health Technology Assessment (HTA)-bodies’ procedures may be helpful.
Cooperation between the EMA and national HTA-bodies has been intensified based on the common goal to foster an early and broad access of EU patients to innovative medicines. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been important contributors.
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