Conditional and accelerated registration of drugs
In the previous article, we reviewed new registration procedures specific to certain drugs in accordance with the requirements of the EAEU. Currently, a drug be approved in the frame of approval procedure with post-registration obligations and in exceptional cases. In addition, Decision 36 also introduces conditional and accelerated registration, which will be discussed in this article.
1. Conditional registration (Section VII.II+Appendix 26).
This type of registration is suitable for drugs intended for the treatment, prevention, or diagnosis of serious (severe) disabling or life-threatening diseases. In this case, applicant can apply for registration before providing comprehensive clinical data. However, in this case, the benefits of earlier availability of the drug on the market should exceed the risk associated with the lack of comprehensive data. If there is an urgent need for such drugs, their registration can be carried out without providing comprehensive preclinical or biopharmaceutical data.
However, conditional registration requires the applicant to complete ongoing research or conduct new studies in order to confirm a positive benefit/risk ratio. The authorized body of a Member State may also determine other necessary conditions.
This procedure implies the validity of the registration certificate for 1 year and requires confirmation of registration (re-registration) with a reassessment of the ratio “benefit – risk” on an annual basis.
If all conditions are met, it is possible to issue a registration certificate for a period of 5 years with subsequent re-registration.
2. Accelerated registration (Section VII.IV+Appendix 27).
In this case, we are talking about an accelerated examination of the following drugs:
- intended exclusively for use by minors;
- which are of particular importance for the health of the population, in particular, in the absence of effective methods of providing medical care.
The period for registration and examination of drugs in the reference state should not exceed 100 working days from the date of filing an application for registration of a drug until the day of issuance of the registration certificate.
To initiate an accelerated procedure, the applicant must send an application to the authorized body of the member state with strong justifications (it should be done before registration procedure).
The period for considering the application and informing the applicant is 40 working days.
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”