For the registration or approval of homeopathic remedies, as for all other remedies, the necessary information regarding the kind and quality of the product must be created and submitted in the CTD format.
However, some special items have to be considered in the case of homeopathics.
It is of major importance to evaluate a suitable strategy for the registration as early as possible and to determine, whether the mother tincture, the first trituration or a certain dilution should be declared as Drug Substance, according with guideline “GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER"
The right decision may have a wide-reaching impact on the finished product line.
Planning stability studies you have to recommend the nature and number of dilutions. These points have major influence on the study protocol (as with reference to “POINTS TO CONSIDER ON STABILITY TESTING OF HOMEOPATHIC MEDICINAL PRODUCTS) For D-Potencies and homeopathic combination products “First Safe Dilution” and “Non-Clinical Safety“ are important key figures. CTD module 3 as well as module 1 also got some other specific items that have to be considered for homeopathic remedies.
From an economic perspective it makes sense to meet the above requirements with established procedures and the necessary expertise to keep the resulting total costs manageable.
Choosing a partner like GBA Pharma, with years of experience in the field of registration of homeopathic remedies, you can gain from our support and have significant economic benefits.
Our team is pleased to advise you individually on all matters related to your product.
Talk to us! We look forward to your request.