Kingdom of Saudi Arabia as a Vice- Deputy of the International Council for Biosimilar Products

2/27/2020
 
The Kingdom of Saudi Arabia represented by the Saudi Food & Drug Authority has elected as deputy chair of “Biosimilar Working Group” for (International Pharmaceutical Regulators Programme), which led by U.S Food and Drug Administration.​

Biosimilars Working Group aims for exchanging information on common concern issues and enabling regulatory cooperation between pharmaceutical regulatory authorities.
This would help to address the complexity of the global pharmaceutical regulatory environment and strengthen cooperation and regulatory convergence.
Moreover, facilitating the implementation of the technical guidelines that related to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The mission of the ICH is to provide a mechanism for evaluating biosimilar products and to build an information-sharing platform by collection of regulatory information, exchange experience between pharmaceutical regulatory authorities, in order to strengthen transparency, provide information for members and public and to help for training the assessors by biosimilar experts.
The council includes members from regulatory authorities as ANVISA (Brazil), COFEPRIS (Mexico), EU EC/EMA, U.S FDA, Health Canada, HAS (Singapore), MFDS (Korea), Japan MHLW/PMDA, PAHO/PANDRH, GHC , Swissmedic, Taiwan FDA, TGA, WHO.