关于当地药品、疫苗和生物制品生产生态系统的案例研究——塞尔维亚背景

A case study on the ecosystem forlocal production of pharmaceuticals,vaccines and biologicalsTheSerbiacontext. A case study on the ecosystem for local production of pharmaceuticals, vaccines and biologicals: the Serbia contextISBN 978-92-4-010534-8 (electronic version)ISBN 978-92-4-010535-5 (print version)© World Health Organization 2024Some rightsreserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike3.0IGO licence (CCBY-NC-SA3.0IGO).Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, providedthe work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHOendorses any specificorganization, products or services. The use of the WHO logo is not permitted. If you adapt thework, then you must license your work under the same or equivalent Creative Commons licence. If you create atranslation of this work, you should add the following disclaimer along with the suggested citation:“This translationwas not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of thistranslation. The original English edition shall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rulesof the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/).Suggested citation. A case study on the ecosystem for local production of pharmaceuticals, vaccines and biologicals:the Serbia context. Geneva: World Health Organization;2024. Licence:CCBY-NC-SA3.0IGO.Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/.Sales, rights and licensing.To purchase WHO publications, seehttps://www.who.int/publications/book-orders. Tosubmit requests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such as tables,figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtainpermission from the copyright holder. Therisk of claims resulting from infringement of any third-party-ownedcomponent in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publication do not implythe expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory,city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed linesonmaps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietaryproducts are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication. However,the published material is being distributed without warranty of any kind, either expressed or implied. Theresponsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable fordamages arising from its use.The published material is valid at the time of writinginJune to August2022.Due to the methodology used to collectthe information, this publication presents country statistics which do not necessarily represent official WHO statistics.Photo credits: © Alamy Stock Photo/Hanna KuprevichPhoto credits: © Alamy Stock Photo/Alexander VedmerPhoto credits: © iStock/SolovyovaPhoto credits:©WHO/Blink Media-Martyn Aim. Portrait of a medical doctor standing outside KBC Bezanijska Cover image:Kosa Hospital ContentsPreface……………………………………………………………………………………………………………………………………………...vAcknowledgements…………………………………………………………………………………………………………………………..viAbbreviations…………………………………………………………………………………………………………………………………..viiExecutive summary…………………………………………………………………………………………………………….…………..viii1.mRNAVaccines………………………………………………………………………………………………………………………………11.1 The Serbian ecosystem: local mRNA vaccine production…………………………………………………………………..11.1.1The national policies which promote and hinder localmRNAvaccine production……………..11.1.2 Financing policies and mechanisms for the production of mRNA vaccines…………………………11.2 Financing bodies……………………………………………………………………………………………………………………………….11.2.1 The Science Fund……………………………………………………………………………………………………………….21.2.2 The Innovative Fund………………………………………………………………………………………………………….21.3 Fiscal incentives to promote R&D……………………………………………………………………………………………………..41.3.1 Regulatory (pharmaceutical sector)…………………………………………………………………………………..61.4 Marketing authorization……………………………………………………………………………………………………………………91.4.1 Iss