The member companies own the technical registrations on the active ingredient and include: Dow AgroSciences, Nufarm, Ltd. and Agro-Gor Corporation.
In addition, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
It is one of the most successful of all the initiatives established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
This group started by presenting the scope of the ICH M7 guideline (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, M7 (R1) 2015).
Diafouka also works on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project, which brings Europe, Japan, and the United States together to find a common language to describe the medicines in use in their regions.
Regulatory guidance regarding JAS is available from The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M3 R2) guideline and from more specific guidance documents issued by the Food and Drug Administration FDAas as well as the European Medicines Agency EMAA).
Life cycle management of a global product often requires managing multiple specifications required for different countries (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q12 Concept Paper 2014).
The developed method was validated as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use guidelines for linearity, range, accuracy, precision, robustness, limit of detection, limit of quantitation and specificity.
The reversed-phase HPLC method has been validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine SIL in pharmaceutical dosage form.
