The second meeting on the implementation of eCTD in Ukraine took place, where market participants had the opportunity to receive answers to questions received since the previous meeting and to discuss further steps.
Electronic Common Technical Document (eCTD) is a standard used in many countries for the transfer of technical regulatory documentation for the registration of medicinal products. It was developed by the International Conference for Harmonization (ICH) to unify the format of information exchange between market representatives and regulatory authorities.
At the regular meeting, based on the results of the processed proposals, updated drafts of the M1 specification for Ukraine were presented with recommendations on the submission of materials and validation criteria.
In addition, it is planned to hold the next meeting, during which the conditions and chronology of the test period and, in the future, the full launch of the system will be discussed.
Among the next steps in the direction of the implementation of eCTD in Ukraine, the following are defined:
approval of the M1 specification for Ukraine with recommendations for submission of materials and validation criteria;
preparation, sending to stakeholders and posting on the official website of technical service files based on the approved M1 specification for Ukraine and validation criteria;
modernization of the software taking into account the approved M1 specifications for Ukraine and validation criteria;
involvement of participants who wish to participate in the submission of eCTD during the test period;
launch of the test period and further work with applicants.
The eCTD standard is used in Europe, the USA and is gradually being implemented by the regulators of other countries of the world, such as Australia, Canada, Bahrain, Qatar, Kuwait, UAE, Oman, Saudi Arabia, Thailand, etc.
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