At the end of March 2022, Decision No. 36 of the EEC Council came into force, which introduced some adjustments to the existing drug registration system (Decision No. 78). For example, the following “types” of marketing authorization became possible: registration of drugs with post-registration obligations, registration of drugs in exceptional cases, conditional registration of drugs, accelerated registration of drugs. In this and the next article, we’ll review these procedures.

1. Registration of drugs with post-registration obligations (Section VII.I + Appendix No. 1).

In this case, the authorized body (expert organization) of the reference state may establish one or a few of the following additional requirements:

• inclusion of certain measures to ensure the safe use of drugs in the risk management system;
• conducting post-registration studies on drug safety;
• establishment of additional requirements for registration of drugs and submission of reports on suspected adverse reactions;
• conducting post-registration studies of the effectiveness of drugs, if necessary, studies of various aspects of the effectiveness of drugs that cannot be studied before the launch of the drug;
• other conditions or restrictions for the safe and effective use of drugs in accordance with the requirements of the Rules of Good Pharmacovigilance Practice of the EAEU.

The established conditions and restrictions, as well as the deadlines for their implementation, are indicated in the registration certificate, the unified register, in the summary of product characteristics (SmPC) and in the instructions for medical use.

In addition, the condition for registration and confirmation of registration (re-registration) of a drug by an authorized body (expert organization) may be an obligation for the holder to conduct:

• Post-registration studies on the safety of drugs in case of concerns about the risks associated with the use of drugs.
• Post-marketing studies of the efficacy of drugs, if the understanding of the disease or clinical methodology shows that previous efficacy assessments require significant revision.

The holder of the registration certificate has the right to submit an explanation in response to the introduction of the obligation within 90 working days from the date of receipt of the relevant notification from the authorized body (expert organization).

Based on the explanation, the authorized body (expert organization) must withdraw or confirm the obligation to conduct studies within 20 working days.

In case of confirmation of this obligation, the conditions for registering the drug must be changed (by including relevant provisions in them), as well as the risk management system.

2. Registration of drugs in exceptional cases (Section VII.II + Appendix No. 25).

Registration can be carried out if the applicant can prove that he is unable to provide comprehensive data on the effectiveness and safety of the drug under normal conditions of its use in virtue of objective verifiable reasons, which must meet one of the following grounds:

• indications for use for which drugs are proposed are so rare that the applicant can reasonably not expect to receive full confirmation of evidence of effectiveness and drug safety.
• at the current state of scientific knowledge, exhaustive information on the efficacy or safety of drugs cannot be provided.
• obtaining information about the efficacy or safety of drugs will contradict generally accepted principles of medical ethics.

In this case, the applicant must fulfill the following obligations:

• to complete a certain safety or effectiveness research program, the results of which allow for a second assessing the benefit/risk ratio within the period established by the authorized body of the reference member state.
• the drug should be classified as “prescription drugs” and in certain cases should be used only under strict medical supervision (for example, in hospital), and for radiopharmaceuticals – use under the supervision of an authorized person;
• summary of product characteristics, instruction for the medical use of the drug (leaflet), registration certificate and any medical information must contain information that attracts the user’s attention that the available data on the drug are insufficient to confirm certain aspects of safety or efficacy.

References:

1. Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
2. 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”