Ever since the electronic submissions initiated, there are growing instances that both health authorities and drug manufacturers are being benefitted. Intended to make it the same situation for human medicines manufacturers in its jurisdiction, the Health Products Regulatory Authority – HPRA (formerly known as Irish Medicines Board [IMB]) is now in plans to implement the eCTD (electronic common technical document) format as mandatory towards the end of 2018.

Just at brink of the FDA’s first phase deadline for eCTD submissions (May 5, 2017), the announcement from the HPRA comes as a strong evidence to consider probably the eCTD is in limelight. By the end of 2018, all human medicines including herbal and homeopathic, must submit their applications in eCTD format is what the HPRA has firmly and officially mentioned. The proposed mandatory eCTD submissions for human medicines will be in line with that of the eSubmission roadmap.

In line with eCTD guidance, which the HPRA decided to continue to follow, there is no requirement of eCTD baseline submissions. However, they are recommended and if required, the agency can request organizations for further information or baseline submissions at any time. That clearly states human medicine manufacturers should be ready with the data for the HPRA baseline eCTD submissions.

Overall, with the beneficial scenario for both the health authorities – reducing review times, and drug manufacturers – saving on costs and time to market, the format of electronic submissions is taking industry by the storm. To sustain the eCTD transition, the responsibility lies with the drug manufacturers to adopt to change and equip their efforts with a suitable and proven publishing and submission software. Act now.


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