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AstraZeneca-SKBio in South Korea and Serum Institute of India
Taking the whole of Africa approach to fighting the COVID-19 pandemic has and will continue to require coordinated efforts from multiple stakeholders from across the continent. Africa CDC would like to acknowledge the deep partnership and continued support of AUDA-NEPAD, AVAREF, WHO AFRO, the Bill a... more
24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, th... more
he Framework sets the requirements for facilities handling High Consequence Agents and Toxins (HCATs) and guides the implementation of laboratory biosafety and biosecurity practices associated with the design, commissioning, routine operation safe and secure biocontainment laboratories.
7 June 2021 The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat... more
24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ... more
Replacement of Annex 2 of WHO Technical Report Series, No. 964... more
The purpose of this handbook is to provide guidance to Member States on the practical aspects of maintaining sanitary standards at international borders at ports, airports, and ground crossings (points of entry) as set out in the International Health Regulations (2005). It provides technical advice ... more
African Union and the Africa Centers for Disease Control and Prevention’s Africa Regulatory Taskforce has endorsed the Emergency Used Authorization for Janssen COVID-19 Vaccine 10 March 2021
The global pandemic has highlighted fragility in international supply chains and the dependency of many African countries on imported personal protective equipment (PPE). Market pressures have also increased prices for imported supplies and put additional pressure on areas with limited resources for... more
PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato... more
Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses. These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p... more
This policy document is to guide the Traditional, Complimentary and Alternative Medicine practices in Rwanda. The various elements examined under the policy include, legislation and regulatory control, registration, manufacture, procurement and supply management, rational use, quality assurance, co-... more
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a... more
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
This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj... more
Comprehensive Reviews in Food Science and Food Safety, Vol.12 (2013) pp.234-248 In 2006, the Institute of Food Technologists (IFT) published an Expert Report entitled “Antimicrobial Resistance: Implications for the Food System” (IFT 2006). That report summarized current scientific knowledge pe... more
Small drinking-water supplies commonly experience operational, managerial, technical and resourcing challenges that impact their ability to deliver safe and reliable services. The needs and opportunities associated with these supplies therefore warrant explicit consideration in policies and regulati... more
Act 9 of 2016
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... more