Regulatory affairs digest of the first half of 2018 for CIS region

In this digest you can find the most important news on issues of registration, safety management, and quality of medicinal products in post-soviet countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan for the first half of 2018:

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The highest activity has been observed in the Eurasian Economic Union (ЕАEU): medicinal products registration under the Unified Rules was formally started as of March 1. The new procedure allows submission of Application forms for registration in five participating countries according to the “sequential” and “parallel” registration procedure. Since the beginning of this year, related legislative acts have been approved and come into effect: the accelerated procedure for registration of vaccines has been introduced and quality requirements for various dosage forms, stability studies, validation, etc. have been approved.

In Kazakhstan, in addition to the start of work under the EAEU Unified Rules, new format of Application forms for registration procedures have been approved since the beginning of this year, the new procedure for submission of registration dossiers has been introduced and some legal aspects have been specified.

In Kyrgyzstan, the Law “On Circulation of Medicinal Products” came into effect in February. This law contains a number of changes aimed at harmonization of the national legislation with the EAEU Unified Rules, and also introduces the accelerated registration for medicinal products imported from the countries with strict regulatory requirements, changes the procedure and timelines of registration, and introduces unlimited Marketing Authorization.

In August, the relevant authority published the information letter with requirements for providing information on the QPPV (Qualified Person Responsible for Pharmacovigilance) in Kyrgyzstan, and also specified the procedure for change of QPPV.

In Ukraine, in April, the changes have been introduced to the procedure for expert examination concerning the requirements for biotechnological medicinal products. In April, the new edition of the Guide on Good Pharmacovigilance Practices (GVP) also came into effect.

In June, minor changes in the authenticity procedure for the medicinal products authorized with the purpose of procurement by specialized organizations have been approved.

Since the beginning of the summer, the relevant Associations, the Ministry of Health and the pharmaceutical community have been actively discussing ways out of the current situation with the introduction of requirements for labeling of medicinal products using SI units as of January 1, 2019.

In Uzbekistan, the new Regulation on the state registration of medicinal products has been approved in March, and the expert examination function has been delegated to the State Center for Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health. The timelines of the specialized expert examination were reduced depending on the type of Application from 180 to 50-155 days.

In April, the new Regulation on the procedure for informing on adverse reactions has been approved, timing of informing has been defined and the local Notification Form has been introduced.

It is planned to introduce the simplified procedure for registration of medicinal products by recognizing authorization in countries having high regulatory requirements.

For more detailed information, please refer to the following pages of the digest or contact us by e-mail info@cratia.ua or by phone +38 044 332-42-94.