Subgroup 1 Ch-J Chan Taiwan E J Argento

Зарегистрируйтесь, чтобы просмотреть полный документ!

Subgroup 1 Ch-J Chan (Taiwan) E. J. Argento (Camevet) K T Domaghi (WAEMO/UEMOA) C. W. Lim (Singapore)

Bioequivalence and old/generics products • Is there generic or BE legislation? – West Africa: yes – Rest: not yet • Different levels of regulatory powers – Singapore: no animal drug regulation yet • Plan to recognize existing foreign approvals with good track record • Otherwise normal assessment of Q, S and E

Different levels of regulatory powers (2) • Argentina – Developing new guidance by legislators in consultation with industry • Remaining discussion mainly on biowaivers – Will be submitted to Camevet later for adoption as a recommendation • Taiwan – Plan new bioequivalence legislation by 2019 – For now generics approvable if • Same API (quantity and quality) • Immediately after first approval of a VMP

Different levels of regulatory powers (3) • West Africa – Based upon European system – Generics possible if • • Reference 10 yrs on market Same composition (Quantity and quality) Same formulation BE demonstrated – Biggest issue: companies try generic route but have no BE data

Biggest challenges faced • West Africa: companies try generic route but have no BE data (incomplete dossier) • Common issue • – Camevet: • Getting to final GL in Argentina • Different implementation speed in Camevet countries • Taiwan – Establish the new legislation timely (2019) – Will face lots of complaints by industry • Singapore – Product classification human vs animal drugs

Pharmacovigilance • All consider this a high priority • Camevet: – no system yet, but authorities can investigate • Taiwan, Singapore : – not covered in current law – Working through existing animal health & welfare laws • West Africa – Ph. V system is not yet foreseen in law – But implementation will be done step by step • First regulatory approval • Later Pharmacovigilance system

Скачать презентацию Subgroup 1 Ch-J Chan Taiwan E J Argento

f382d8a899d3eded99b102da700c2fb2.ppt

Количество слайдов: 6