Since April 2013, we have been providing support in implementation of “Risk management plan (RMP)”, which has become a mandated requirement for new drugs and biosimilar, and RMP needs to be submitted at marketing approval application.
As a manufacturer of pharmaceutical products itself, CMIC Group has been implementing post-marketing safety measures with an eye on clinical development, approval application and RMP. As for support in implementation of RMP, we can provide you with a plan to create and operate on the RMP by utilizing the know-how gained through CMIC Group’s approval application work.
- Creation of new RMP
- Creation and operation under additional Pharmacovigilance plan
- Creation and operation under additional Risk minimization action plan
- Regular review / revision of the entire RMP