BO session on Generics Feedact from Egypt,

sherrill-nordquist
Published  · 8 slides · 0 views
↓ Download
BO session on Generics Feedact from Egypt,
1 / 1
BO session on Generics Feedact from Egypt, - slide 1 of 8 BO session on Generics Feedact from Egypt, - slide 2 of 8 BO session on Generics Feedact from Egypt, - slide 3 of 8 BO session on Generics Feedact from Egypt, - slide 4 of 8 BO session on Generics Feedact from Egypt, - slide 5 of 8 BO session on Generics Feedact from Egypt, - slide 6 of 8 BO session on Generics Feedact from Egypt, - slide 7 of 8 BO session on Generics Feedact from Egypt, - slide 8 of 8
Description
BO session on Generics Feedact from Egypt, republic of korea and ukraine 7120XX Pitch deck title 2 Egypt No distinction between generic applications and non-generics Reference made to a product containing the same active ingredient,

Related Topics

Download this presentation From Below

"BO session on Generics Feedact from Egypt," is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Presentation Transcript

01
BO session on Generics Feedact from Egypt, republic of korea and ukraine<br>
02
7/1/20XX Pitch deck title 2 Egypt No distinction between generic applications and non-generics

Reference made to a product containing the same active ingredient, authorised by a stringent authority

Assessment is focused on Quality

BE is not required

Acceptable differences compared to reference product:
- different salts

The authorisation in Egypt may differ from that in the stringent authority – eg, different indication and species

Regulatory authorities would like to require BE but would require change to legislation

No data protection rules apply<br>
03
7/1/20XX Pitch deck title 3 Republic of korea Generic product must be same type, have same specification and quantity of active ingredient as a reference product

Same dosage form, target animal(s), efficacy, dosage and withdrawal period

Initial assessment is focused on Quality specifications and manufacturing, including stability data

BE is required in those cases where there are differences compared to reference product and where Quality and manufacturing review indicate that absorption may not be same as for refence product

VICH GL52 is used but there is also local guidance

Generic applications for vaccines are possible where product is same type, concentration of active substance is same, dosage form is same and the same manufacturing site of the final bulk solution

Data protection: 4 to 6 years<br>