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- Guideline on the chemistry of active substances - European Medicines Agency
This guideline is applicable to active substances that have been developed following a “traditional” or an “enhanced” approach, as described in ICH Q8-11 (Refs 1-4), or a combination of these
- New Active Substance categorisation and Orphan Similarity
“Where the active substance of essentially similar medicinal product contains the same therapeutic moiety as the original authorised product associated with a different salt ester complex derivative evidence that there is no change in the pharmaco-kinetics of the moiety, pharmacodynamics and or in
- Chemistry of active substances (chemistry of new active substances . . .
This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP QWP 130 96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a) It has been revised to cover new and existing active substances in one guideline
- Section 2: Qualitative and quantitative composition
When active moiety is an active substance of an already approved medicinal product, the quantitative composition should also be stated in terms of quantity of active moiety (e g 75mg of fosphenytoin is equivalent to 50mg of phenytoin) e g Each patch contains 750 micrograms of estradiol in a patch size of 10cm2, releasing
- RP on the chemical structure and properties criteria to be considered . . .
If the chemical active substance is structurally related as a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an already approved active substance(s) in the European Union, it should be assessed whether it shares the same therapeutic moiety at the site of the biological activity
- Criteria to be considered for the evaluation of new active substance . . .
Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances Draft: consultation closed Consultation dates: 18 11 2022 to 31 05 2023 Reference Number: EMA CHMP CMDh CAT BWP 828612 2022 Summary:
- Medicines for human use under evaluation - European Medicines Agency (EMA)
The INN contains only the active moiety for generic medicines and biosimilar medicines, with no information on salt, ester or derivative The lists are available in Excel format from February 2021 to support data sorting and filtering
- Quality: active substance | European Medicines Agency (EMA)
The European Medicines Agency's scientific guidelines on the quality aspects of active substances help medicine developers prepare marketing authorisation applications for human medicines For a complete list of scientific guidelines currently open for consultation, see Public consultations
- Detailed guide regarding the monitoring of medical literature and the . . .
More specifically, active substances contained in medicinal products for which a high number of marketing authorisations were granted to various MAHs in the EEA are selected They are grouped as follows: i Substances by active moiety including e g salts, esters a s well as combinations (hereafter referred to as “substance groups”) ii
- Guideline on the chemistry of active substances - European Medicines Agency
59 control of active substances (existing or new chemical entities) used in a medicinal product The 60 differences in requirements for new or existing active substances are clarified in the relevant 61 paragraphs of the guideline where applicable For the purposes of this guideline, an existing active
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