Value Added Medicine definition as per the JFDA: It is a medicine that has been modified or developed from the reference medicine, where the amendment would consider the medicine with a technology that increase the effectiveness/safety of the drug or give it an advantage /extra value for the benefit of the patient

Though the Hybrid applications or 505 (b)(2) applications have been adopted worldwide by many reference stringent authorities it is still not adopted in the Middle East and North Africa Region (MENA). The Jordanian FDA authority being one of the pioneers in MENA started working on the guidelines and issued the final approved version last year referencing the EMA/USFDA in most of the cases. This guidance will grant and open the door for many local manufacturers and international companies to work on new combinations and new value added medicine considering the many faced challenges and restrictions regarding the generics e.g Patent, Prices, competition etc.

The guidance might grant fast tract assessment and higher prices if the drug proved to be of added value and on the other hand this will be the starting trigger for other authorities in MENA region to develop and establish their guidelines, submission pathways.

I have attached the JFDA guidelines ( though it is in Arabic, yet in the last pages the summary for the drug application type selection is key to go through as for the rest of the guidelines it is explained in details through the addition two lectures attached that were presented during the annual JFDA congress highlighting the  JFDA experience.