This consists of several mAbs including 3 infliximabs. China-has authorized 1 biosimilar (rituximab) in 2019. Cuba-has authorized 6 biosimilars including 1 somatropin (the 1st authorized biosimilar in 2014) and 5?mAbs (3 of them produced in Russia). Egypt-has 4 authorized biosimilar products including 2 filgrastims. Regulatory recommendations, Survey, WHO 1.?Intro The World Health Organization (WHO) is not a regulatory expert, but it has a clear Mepixanox mandate to support regulatory government bodies Mepixanox in its 194 Member Claims. More precisely, one of the WHO core functions is definitely establishing norms and requirements and advertising and monitoring their implementation. The WHO Mission in the context of the rules of biologicals is definitely to provide paperwork with globally agreed principles and specialists suggestions that serve as a basis for creating or updating national regulatory requirements. WHO recommendations and recommendations for vaccines and additional biologicals are considered as WHO written standards and they also serve as a basis for WHO prequalification. The WHO recommendations within the evaluation of related biotherapeutic products (SBPs; hereafter referred to as the Guidelines) [1] were developed to provide a globally suitable set of basic principles for licensing biosimilars and to serve as a basis for establishing national licensing requirements. Since the adoption of the WHO Recommendations from the Expert Committee on Biological Standardization (ECBS) in 2009 2009, several WHO implementation workshops have been held to discuss the WHO Recommendations with regulators and manufacturers from more than 60 countries. Regulators in WHO Member Claims are playing a pivotal part in implementing WHO guiding principles in their national Mepixanox regulations. WHO is facilitating that process by organizing implementation workshops with lectures, case studies and review of examples of product approvals which serve as opportunities to discuss medical but also practical elements in the discussion board of regulators, manufacturers and academia. The key lectures, results of the discussions and reports from countries have been published including very useful case studies [[2], [3], [4], [5], [6], [7], [8], [9]]. Prior to the workshops, in most Rabbit Polyclonal to RRS1 cases, WHO carried out a survey to capture the status of national requirements related to the regulatory evaluation of such products with particular emphasis on whether or not the current WHO Recommendations had been, or were to be, integrated into national requirements. Towards WHO attempts on biotherapeutics, WHO developed the WHO recommendations on post-approval changes to biotherapeutic products which were used from the WHO ECBS in 2017 [10]. Since the need for advertising and assisting Member Claims in implementation of WHO requirements has been clearly Mepixanox recognized, the first implementation workshop for these recommendations was planned to take place from 25 to 26 June 2019 in Seoul, Republic of Korea. As a part of the preparation for the workshop, a survey was carried out among the 20 workshop participating countries to review the current scenario on rules and authorization of biotherapeutic products and SBPs (also called biosimilars) as well as summarize any difficulties encountered. The encounter with the survey carried out previously, in 2010 2010 was that many countries and areas had made progress in developing a regulatory platform for biotherapeutic products including SBP. However, it also exposed problems with improper software of the principles outlined in the 2009 2009 WHO Recommendations [11]. As Mepixanox explained above, WHO has offered considerable effort and assistance to regulatory government bodies in implementing the principles of evaluation included in the recommendations into regulatory practice. One example of these attempts is the recent publication of a Q&A document to complement the WHO Recommendations for biosimilars [1,12]. The questions in the document were selected on the basis of those regularly asked by regulators during implementation workshops on the 2009 2009 WHO Recommendations conducted during the past nine years. The expectation of WHO is the Q&A document will provide medical and regulatory upgrade and clarity for the users of WHO Recommendations. From the survey carried out in 2019, WHO seeks to update the information within the global scenario and determine areas where further support to its Member Claims needs to become offered. In this article, the information accrued on rules and authorization of SBPs in the countries participating in the survey are offered and discussed. The findings on difficulties and long term opportunities will become published in a separate article in the near future. 2.?Strategy For the survey, a questionnaire was prepared by Who also in the form of a template for completion by participating regulatory government bodies. The template was related to that utilized for the previous (August 2010) WHO survey [11] but updated to include additional data such as classification of insulin.