Update

EMA guideline on the chemistry of active substances 

EMA guideline on the chemistry of active substances 

EMA guideline on the chemistry of active substances 

The EMA recognized the need to update the guideline on the chemistry of active substances (EMA/454576/2016). This update will be (amongst others) based on the lessons learnt from the experience in the management and risk mitigation of N-nitrosamines, and the need to use this experience in the revised guideline to apply to other ‘cohort of concern’ (CoC) impurities and other potent toxins. Therefore, the EMA published their Concept paper on the revision of the guideline on the chemistry of active substances, which is open for public consultation.

It is already advisable for active substance manufacturers to look at the aspects mentioned in this concept paper during their ongoing active substance development. Aspect to take into account as discussed in the paper are:

  • Appropriate process development to mitigate as much as possible the presence of N-nitrosamines, CoC compounds and other potent toxins
  • Clear information on all materials used in the process (function, quantities, potential contaminants, overall quality)
  • Discussion regarding the presence or formation of, control options for, and formation during storage of N-nitrosamines, CoC compounds as well as other potent toxins
  • Use of recycled materials

Do you need support in the development or registration of your active substance? The experts at STARoDub B.V. know how to find their way in the regulatory landscape. Don’t hesitate to contact us for support at info@starodub.nl

EMA guideline on the chemistry of active substances