The Ministry of Health Will Register the First Drug Under a Simplified Procedure

On July 20, 2017, the State Expert Center of the Ministry of Health of Ukraine presented a report on approval of registration materials for a medicinal product within the framework of a simplified procedure for registration of innovative medicines from countries with a severe regulatory system, which has been posted on the official website. Since the introduction of this procedure (December 30, 2016), three manufacturers have submittedtheir applications for registration, but only the latter has passed the expertise of the State Expert Center.

Let us remind you that within the shortened procedure, the innovative drugs that have already been registered by the competent authority of the United States, Switzerland, Japan, Australia, Canada, as well as medicines that are registered in a centralized procedure by the competent EU authority, can be registered for use on territories of these countries or EU member states within 17 days.

Now, most of the problems that arise when assessing the registration materials of the State Expert Center, which are the basis for registration rejection, are related to the following factors:

• The lack of an opportunity to obtain clarification from the applicant for particular data from the registration materials and, as a consequence, the need for the SEC to reject applications in the event of any material mismatch;
• The difficulty in verifying the medicinal product registration fact on the official websites of regulatory authorities due to the search difficulty on the sites of different countries;
• Difficulty in confirming the applicant's changes to the registration dossier in the country of registration due to the lack of such information in public access in some countries;
• Incorrect translation of instructions to the drug, which is given in an arbitrary form and does not require notarization.

Let us remind you that on June 21, 2017, the SEC published the draft amendments to the Order of the Ministry of Health of Ukraine dated November 17, 2016 No. 1245 "On Approving the Procedure for Processing Registration Materials for Medicines Submitted for State Registration (Re-registration), and Materials on making changes to registration materials during the validity period of the registration certificate for medicinal products registered by the competent authorities of The United States of America, Switzerland, Japan, Australia, Canada, medicines registered under a centralized procedure by the competent authority of the European Union" on its website for public review. The document has been designed to resolve the above contradictions. It is expected that the project will be published on the website of the Ministry of Health of Ukraine.

The adoption of a positive decision by the SEC will soon take shape of the first decision of the Ministry of Health on the innovative drug state registration under the simplified registration procedure for medicines from countries with a severe regulatory system. Transition to positive dynamics of decisions and introduction amendments to the procedure for conducting simplified registration of this drug category should eliminate the existing obstacles in the documents procession and lead to an increase in the demand for participation in it among market parties.