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Relevant bibliographies by topics / Medicines registration harmonisation in SADC

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Academic literature on the topic 'Medicines registration harmonisation in SADC'

Author: Grafiati

Published: 4 June 2021

Last updated: 8 February 2022

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Journal articles on the topic "Medicines registration harmonisation in SADC"

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Sithole, Tariro, Gugu Mahlangu, Sam Salek, and Stuart Walker. "Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative." Therapeutic Innovation & Regulatory Science 54, no. 6 (2020): 1319–29. http://dx.doi.org/10.1007/s43441-020-00154-y.

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AbstractThe Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics for the work done by the initiative are available in the literature, but there has not been a critical review of the process, including an analysis of factors contributing to the success of the initiative and conversely those negatively affec

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Ahammad, Nisar, Nagarjuna Reddy, M. V. Nagabhushanam, and Brahmaiah Ramakrishna. "Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 673–79. http://dx.doi.org/10.22270/jddt.v9i4-s.3334.

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Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic commo

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Martin Lasanta, Agustin. "OC 8715 GOING FURTHER TOGETHER: THE ROLE OF THE EU IN SUPPORTING REGULATORY HARMONISATION OF HEALTH TOOLS IN AFRICA." BMJ Global Health 4, Suppl 3 (2019): A16.2—A16. http://dx.doi.org/10.1136/bmjgh-2019-edc.39.

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BackgroundOn May 20, 2018, African governments adopted the Treaty for the establishment of the African Medicines Agency (AMA) as a stepping stone in the strengthening and harmonising of medical products regulation on the continent. Many countries in Africa lack robust and comprehensive regulatory systems supporting the research and registration of health products, hampering the translation of health research and innovation into public health impacts. The AMA could substantially improve the access to quality-assured, safe andeffective health solutions and technologies in Africa and around the

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Skulberg, Arne Kristian, Ida Tylleskär, Anne-Cathrine Braarud, et al. "NTNU intranasal naloxone trial (NINA-1) study protocol for a double-blind, double-dummy, non-inferiority randomised controlled trial comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use." BMJ Open 10, no. 11 (2020): e041556. http://dx.doi.org/10.1136/bmjopen-2020-041556.

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IntroductionIntranasal (IN) naloxone is widely used to treat opioid overdoses. The advantage of nasal administration compared with injection lies in its suitability for administration by lay people as it is needless. Approved formulations of nasal naloxone with bioavailability of approximately 50% have only undergone trials in healthy volunteers, while off-label nasal sprays with low bioavailability have been studied in patients. Randomised clinical trials are needed to investigate efficacy and safety of approved IN naloxone in patients suffering overdose. This study investigates whether the a

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Fowler, J. Corey, Nathan Cope, Jonathan Knights, et al. "Hummingbird Study: a study protocol for a multicentre exploratory trial to assess the acceptance and performance of a digital medicine system in adults with schizophrenia, schizoaffective disorder or first-episode psychosis." BMJ Open 9, no. 6 (2019): e025952. http://dx.doi.org/10.1136/bmjopen-2018-025952.

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IntroductionIn patients with schizophrenia, medication adherence is important for relapse prevention, and effective adherence monitoring is essential for treatment planning. A digital medicine system (DMS) has been developed to objectively monitor patient adherence and support clinical decision making regarding treatment choices. This study assesses the acceptance and performance of the DMS in adults with schizophrenia, schizoaffective disorder or first-episode psychosis and in healthcare professionals (HCPs).Methods/AnalysisThis is a multicentre, 8-week, single-arm, open-label pragmatic trial

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Battershill, Jon M., and R. J. Fielder. "Mouse-specific carcinogens: an assessment of hazard and significance for validation of short-term carcinogenicity bioassays in transgenic mice." Human & Experimental Toxicology 17, no. 4 (1998): 193–205. http://dx.doi.org/10.1177/096032719801700401.

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1 The International Conference on the Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for human use (ICH) has agreed that bioassay data from only one species, the rat, supported by appropriate mutagenicity and pharmacokinetic data and also information from new (unvalidated) short term in vivo screening tests for potential carcinogenicity, could be used for the licensing of human medicines. This proposal has been supported by reviews of the utility of testing pharmaceuticals in the mouse which have concluded that the mouse bioassay contributes little to regulator

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Sithole, Tariro, Gugu Mahlangu, Velma Capote, et al. "Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward." Frontiers in Medicine 8 (August 27, 2021). http://dx.doi.org/10.3389/fmed.2021.742181.

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Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review

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Sithole, Tariro, Gugu Mahlangu, Velma Capote, et al. "Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward." Frontiers in Medicine 8 (August 27, 2021). http://dx.doi.org/10.3389/fmed.2021.742200.

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Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration process

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Dissertations / Theses on the topic "Medicines registration harmonisation in SADC"

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Dhanraj, Keshnee. "Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)." University of the Western Cape, 2021. http://hdl.handle.net/11394/7956.

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Magister Pharmaceuticae - MPharm<br>Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of

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Ratlabyana, Mphako Brighton. "Transparency in medicines registration decision making: A closer look at National Medicines Regulatory Authorities (NMRAs) within the Southern African Development Community (SADC) region." University of the Western Cape, 2020. http://hdl.handle.net/11394/7921.

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Magister Pharmaceuticae - MPharm<br>Medicines registration decision-making and regulatory best practice involve transparent and consistent rule making and processes with publicly available published assessment decisions and reports (Kaine, 2020). Publication of information relating to evaluation of medicines in the form of Public Assessment Reports (PARs) is one way of ensuring transparency in medicines registration decision making. It is however not clear whether National Medicines Regulatory Authorities (NMRAs) in the Southern African Development Community (SADC) region are in a position to

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