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1988
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Guidelines on Drug Registration Applications in Botswana

Drugs Advisory Board, Republic of Botswana (Gabarone, Botswana) (2000)
First Revised Edition March 2000
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Registration Guidelines for Medical Devices Bangladesh 2015

Directorate General of Drug Administration,, Ministry of Health and Family Welfare, People's Republic of Bangladesh (2015) C1
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Guidelines for Registration of Medicines and Health Products in Liberia

Liberia Medicines and Health Products Regulatory Authority (LMHRA) (2012) C1
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Rwanda: MOH GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Ministry of Health, Rwanda (2014) C2
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M... more
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A Guide to the Registration, Licensing and Scheduling of Medicinal Products in Malawi

Pharmacy, Medicines and Poisons Board, Malawi (2002) C2
First edition, November 1997 | Revised July 2002
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Medicine's registration procedure in Madagascar

Ministry of Health, Madagascar (2016) C1
Procedures Manual - Medicines registration in Madagascar - 2016 version
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Sierra Leone: GUIDELINES FOR MEDICINAL PRODUCT REGISTRATION

Pharmacy Board of Sierra Leone (PBSR) (2015) C2
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Namibia: Application for Registration of a Medicine

Ministry of Health and Social Services (MOHSS) (2014) C2
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
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Uganda: THE NATIONAL DRUG POLICY AND AUTHORITY (REGISTRATION) REGULATIONS, 2014

The Government of Uganda The Uganda Gazette (2014) C2
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.
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Zambia: THE MEDICINES AND ALLIED SUBSTANCES ACT, 2013

The Government of Zambia (2013) C1
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie... more
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South Africa: GUIDELINES FOR THE REGISTRATION OF MEDICINES

Medicines Control Council (MCC), Department of Health Republic of South Africa (2012) C1
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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Zambia: GENERAL GUIDELINES FOR SUBMITTING APPLICATIONS FOR REGISTRATION OF A MEDICINE

Zambia Medicines Regulatory Authority (ZAMRA) (2016) C2
First Edition
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Tanzania: GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Tanzania Food & Drugs Authority (TFDA) (2015) C2
First Edition
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GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF A MULTISOURCE (GENERIC) FINISHED PHARMACEUTICAL PRODUCT (FPP): QUALITY PART IN THE COMMON TECHNICAL DOCUMENT (CTD) FORMAT

Medicines Control Authority of Zimbabwe (MCAZ) (2012) C2
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Botswana: Medicines and Related Substances Act

Government of Botswana (2013) C1
A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
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GUIDELINES ON DRUG REGISTRATION APPLICATIONS IN BOTSWANA, 4th edition

Ministry of Health, Gabarone, Botswana (2014)
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Botswana: Guidelines for stability testing of pharmaceutical products

Ministry of Health, Gabarone, Botswana (2009) C2
This guideline is intended to provide requirements to applicants wishing to submit applications for registration of medicines in Botswana.
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Ethiopian Food and Drug Authority Website

Ethiopian Food and Drug Authority (2022) CC
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit... more
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Practical manual on tuberculosis laboratory strengthening, 2022 update

World Health Organisation (WHO) (2023) C_WHO
The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la... more
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Efficacy and Safety of Pafuramidine versus Pentamidine Maleate for Treatment of First Stage Sleeping Sickness in a Randomized, Comparator-Controlled, International Phase 3 Clinical Trial

Pohlig G, Bernhard SC, Blum J, Burri C, Mpanya A, et al. PLOS Neclected Tropical Diseases (2016) CC
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita... more