Answer:

rCR, an animal-free solution that also reduces dependence on natural resources, are not yet included in the Ph. Eur. To pave the way for their future consideration in the Ph. Eur., the European Pharmacopoeia Commission is encouraging data generation: large volumes of peer-reviewed data and user experience are essential and need to be supported by the approval of medicinal products for which rCRs were used.

Currently, bacterial endotoxin tests involving rCR or any other new reagents are considered to be alternative methods replacing a pharmacopoeial test, as described in the General Notices. Equivalence with one of the methods described in general chapter 2.6.14 is to be demonstrated in accordance with the General Notices and to the satisfaction of the competent authority.