Fixed-dose combination finished pharmaceutical product (FDC-FPP)
With the entry into force of the EAEU registration rules, the classification of drugs has changed significantly, as we wrote in the article “NOMENCLATURE OF MEDICINES WITHIN THE FRAMEWORK OF REGISTRATION ACCORDING TO THE RULES OF THE EAEU”. (https://beawire.com/ru/2020/09/16/nomenclature-of-medicines-within-the-framework-of-registration-according-to-the-rules-of-the-eaeu/). However, the existing classification does not quite clearly describe such category of drugs as FDC-FPP.
It is worth noting that its definition is not presented in the key legislation governing the registration process of drugs, Decision No. 78. However, it can be found in Decision No. 85 on the Regulations for Bioequivalence Research:
combination drug (fixed-dose combination finished pharmaceutical product, FDC-FPP, CLP) is a ready-made drug containing 2 or more active substances (active pharmaceutical substances);
FDC-FPP is often found among diabetes mellitus, anti-tuberculosis and antiviral drugs. These include, for example: Glimecomb (Glibenclamide + metformin), PHTHIZAMAX® (Isoniazide+Pyrazinamide+Rifampicin), etc.
Within the EAEU classification, a combination drug can belong to any group (original, generic, hybrid). Thus, the FDC-FPP does not belong to a separate group.
When registering a FDC-FPP, it is necessary to justify the benefit of the developed combination. Beneficial effects may include the following:
- Increase the effectiveness of the combination compared to monotherapy due to the synergistic effect of its constituents.
- Accelerate component effect.
- Increase safety while maintaining efficiency at the segregated application level.
- Effect when one component disables the adverse drug reactions caused by the other (s).
- Simplify therapy (e.g. reducing the number of pills).
In addition, additional pre-clinical and clinical trials must be provided for registration of a FDC-FPP.
The requirements differ according to (Recommendation No. 25):
- Registration status of active substances in at least one of the EAEU member states (important for the scope of pre-clinical trials).
- Therapeutic scenario requiring different types of evidence of overall efficacy and positive benefit-to-risk ratio (important for clinical scope research).
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”
- Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 N 85 “On Approval of the Regulations for Bioequivalence Studies of Medicines within the Eurasian Economic Commission union”
- Recommendation of the Board of the Eurasian Economic Commission dated 02.09.2019 N 25 “On Guidelines for Preclinical and Clinical Development of FDC-FPP Drugs”
- Yatsenko K.A., Berezina V.S. REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS. Drug development & registration. 2016;(4):222-228. (In Russ.)