Macedonian pharmaceutical bulletin, 68 (Suppl 1) 193 - 194 (2022) Online ISSN 1857 - 8969 DOI:10.33320/maced.pharm.bull.2022.68.03.092 Short communication *alka@ff.ukim.edu.mk S1 PP 77 Regulatory framework for conducting Good Clinical Practice inspections - before, during and after the COVID-19 pandemic Mirlinda Alimi 1 , Zorica Naumovska 2 , Zoran Sterjev 2 , Aleksandra Kapedanovska Nestorovska 2* Agency for Drugs and Medical Devices of the Republic of Northern Macedonia-MALMED, 1000 Skopje, RN Macedonia 2 Faculty of Pharmacy, University “Ss. Cyril and Methodius”, Majka Tereza 47, 1000 Skopje, RN Macedonia Introduction The Principles of Good Clinical Practice (GCP) define international ethical and scientific quality standards in the planning, implementation, monitoring and reporting of clinical trials conducted on humans. In this context, the protection of the rights, safety and well-being of respondents participating in clinical trials is a priority of regulatory agencies worldwide. Verification of compliance with GCP standards is done through audits and inspections as an exclusive right of the regulatory authorities (ICMRA, 2021). Тhe COVID-19 pandemic have significantly affected the conduct of clinical trials (CТs) and posed unique challenges to all parties (sponsors, clinicians and regulators) involved in conducting of clinical trials. In this regard, deviations from the clinical trial protocol and / or protocol violations were inevitable and had a potential to significantly affect the safety of CT participants and the data integrity as most important aspects that defines the accuracy and reliability of the clinical evaluation (Park et al. 2021). In response to the new situation sponsors, researchers and regulators jointly adopted initial guidelines to ensure the safety of participants, data integrity, compliance with GCP principles (Sathian et al., 2020) The overall aim of this study is to review and evaluate the effects of the COVID-19 pandemic on global legislation, practical experience and other allied information related to the planning, implementation, assessment and inspection of clinical trials. The specific objectives include review and analysis of the effect of the COVID - 19 pandemic on the local GCP legislation, guidelines and inspections. Materials and methods We performed a systematic search of published evidence and guidelines for GCP and GCP inspection not favoring any type of product - drug, vaccine or medical device. The data and information were collected using public databases of global regulatory agencies - EMA, PMDA, MHRA and FDA. These regulators were selected because of their active involvement in inspection activities around the world and because of their pioneering acceptance of remote inspections during the COVID-19 pandemic. To supplement the findings and discussions, systematic reviews on this topic were retrieved from Medline via Pub-Med database and Google scholar, using the following predefined keywords: "COVID -19"; "Clinical trial", "good clinical practice", "regulatory agencies", "GCP inspections". Additionally, we searched the official websites of the national regulatory authority- Agency for Drugs and Medical Devices of the Republic of Northern Macedonia- MALMED, regarding the clinical trials approved by the Commission for Clinical Trials of drugs and medical devices in the period of January 2019 - April 2022 and inspections of CT conducted by the Commission for assessment of conditions for Good Clinical Practice at MALMED in the same period. Results and discussion The initial search of the biomedical literature resulted in a total of 156 original scientific papers for further evaluation. Тhe previously set criteria of non-preferences were met by total of 30 papers. Most of them, approximately 50%, were published in the second half of