With the entry into force of the EAEU legislation on the registration of medicines, a whole range of new terms appeared, the understanding of which is key in determining the circulation strategy of the drug in the EAEU member states. One such term is “expansion of geography”.

Expansion of geography — registration of the drug in the EAEU member states, where it was not previously registered, while bringing the dossier in line with the requirements of the EAEU. For example, drug A was registered only in Russia according to national requirements. In any case, the dossier for this drug must be brought into line with the requirements of the EAEU, but the applicant has a choice: to keep the drug only in Russia or enter the markets of other EAEU member states. It is important that the applicant needs to decide whether to expand the geography or not before submitting the dossier, as this will determine the requirements for the registration dossier.

When brought into compliance “without expanding geography”, the drug will be in circulation in the territory of the Member State where it was registered. According to paragraph 178 of Decision No. 78, there is no reassessment of the benefit/risk ratio for such drugs.

In case of bringin in line with the requirements of EAEU with the “expansion of geography” according to paragraph 181 of Decision No. 78, “drugs may be applied for registration under the mutual recognition procedure in the Member States in which this drug was not registered before the entry into force of the Agreement or until December 21, 2020 after its bringing into force registration dossier in accordance with the requirements of the Union”. According to paragraph 178 of the Decision, the benefit/risk ratio is reassessed for such drugs.

Thus, it is important that the information in the registration dossier documents (in particular, in the application and cover letter) does not contradict each other. The cover letter should clearly indicate the reference state; in which states the drug is registered, whether it is planned to register in these states under the mutual recognition procedure; whether it is planned to register under the mutual recognition procedure (after bringing it into compliance in the reference state) in states in which the drug was not previously registered (the state of recognition).

In addition, as mentioned above, “expanding geography” will reassess the benefit/risk ratio, and additional information on research needs to be provided ( for example, bioequivalence studies) It should be remembered that the requirements for studies and their number will depend on the declared drug (type, dosage form, etc.).

It should be noted that it is important to think about expanding the geography at the stage of clinical trials. As noted at the RegLek 2022 conference, a frequent drawback of the registration dossier for some drugs is the non-compliance of the reference drug with the requirements of the EEC regulatory legal acts ( Decision No. 85 and Decision No. 89). When submitting a dossier with geographical expansion, it is necessary to check the relevance of the reference drug.

References:

1. Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022

Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (ed. 23.12.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”