Finland Moves to Electronic Clinical Trial Submissions to Mitigate Postal Strike

| By | Clinical Trials, Finnish Pharma
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The Finnish Medicines Agency is allowing companies to send clinical trial materials via email to mitigate the impact of a postal strike in the country.

Fimea is in the process of moving to electronic submissions of clinical trial materials, with the agency due to accepting annual drug safety update reports (DSUR) via the Common European Submission Portal (CESP) from next week onward. However, Fimea has pulled forward and temporarily expanded its acceptance of electronic submissions in response to a strike by the Finnish postal service.

During the postal strike, Fimea will accept materials via email. Sponsors that take advantage of this temporary option will need to resend the materials, plus a cover letter referencing the earlier electronic submission, in the post once the strike ends. Fimea has also pulled forward the date on which sponsors can start using CESP to file DSUR by one week.

It is unclear how long Fimea will need to keep the temporary measures in place. Finnish postal workers initially planned to strike for two weeks starting 11 November. However, the union has now threatened to extend the industrial action by a further two weeks if negotiators are unable to agree on a new collective bargaining settlement.

SOURCE: fimea.fi
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