BO session on Generics Feedact from Egypt,

Transcript:BO session on Generics Feedact from Egypt,:
BO session on Generics Feedact from Egypt, republic of korea and ukraine 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 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 7/1/20XX Pitch deck title 4 UKRAine Legislation is currently under revision. New legislation will be based on that of EU but… Under a lot of pressure from industry to have a favourable interpretation of EU legislation – eg, accept a reference product authorised in EU (Ukrainian authorities would not have access to dossier) Role of competent authority - no scientific assessment by CA Products are either full or Generics For generics pharmaceutical equivalence is usually claimed Where BE studies are conducted VICH GL is used. EU CVMP GL is also used Data protection will be as in EU but currently there is none Many applications for combination antimicrobial products 7/1/20XX Pitch deck title 5 UKRAine… Many applications for combination antimicrobial products not consistent with prudent use, but no legal basis to reject Generics have an independent life once authorised Reference product may be removed in Ukraine – how to update generic eg, if withdrawal period of reference product on market outside Ukraine changes Responses: Company are responsible for keeping product up to date (take account of new scientific data) In