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Malawi: Drugs
<p>GMP certificate must be shown or, if it is not available, enough information to satisfy reviewers that the materials were manufactured to be ...
Ukraine: Drugs
<p>Products must be manufactured in compliance with GMP and a copy of a valid license to manufacture medicinal products.&nbsp;</p> ...
Ukraine: Vaccines
<p>According to <a href="http://zakon4.rada.gov.ua/laws/show/z0965-11">Order #523</a>, evaluation of an application will b...
Ukraine: Diagnostics
<p>Clinical trial requirments are outlined in Order #616 "<a href="http://zakon1.rada.gov.ua/laws/show/z1461-12">On Approva...
Peru: Drugs
<p>Clinical trials in Peru are approved &nbsp;by the National Health Institute's Research and Technology Transfer General Office. Requir...
Peru: Vaccines
<p>According to "<a href="http://www.ins.gob.pe/insvirtual/images/otrpubs/pdf/Manual%20de%20Proc%20para%20la%20realizacion%20de%20e...
Peru: Diagnostics
<p>Must include a product description, information on packaging material, storage conditions, lot number, expiration date, importer's date, ...
Ghana: Drugs
<p>Procedures for importing products for clinical trial are outlined in &ldquo;<a href="http://www.fdaghana.gov.gh/images/stories/pd...
Ghana: Vaccines
<p>Procedures for importing products for clinical trial are outlined in &ldquo;<a href="http://www.fdaghana.gov.gh/images/stories/pd...
Ghana: Diagnostics
<p>Procedures for importing products for clinical trial are outlined in &ldquo;<a href="http://www.fdaghana.gov.gh/images/stories/pd...
Nepal: Drugs
<p>The DDA oversees national pharmacovigilance activities. Nepal has been a member participant in the WHO Programme for International Drug Monit...
Nepal: Vaccines
<p>Sponsors must provide compensation if there is a trial-related death or injury. If a product demonstrates clinical benefit, sponsors are also...
Nepal: Diagnostics
<p>0 clinical trials approved from September 2012 to September 2014.</p>
Russia: Drugs
<p>Sponsors must have insurance coverage for clinical trial subjects. Insurance much cover death or health impairment.</p> <p>Insura...
Russia: Vaccines
<p>Sponsors must have insurance coverage for clinical trial subjects. Insurance much cover death or health impairment.</p> <p>Insura...
Russia: Diagnostics
<p>According to <a href="http://www.emergogroup.com/resources/russia-process-chart">EmergoGroup</a>,&nbsp;registration...
Mali: Vaccines
<p>The National Public Health Laboratory Drug oversees medicine quality in Mali. Please refer to this 2011 World Bank Health, Nutrition, and Pop...
Bangladesh: Diagnostics
<p>September 24, 2014.</p>
Mozambique : Diagnostics
<p>Septemebr 25, 2014.</p>
Thailand: Vaccines
<p>According to a presentation by Siriporn Chawanon of the Drug Control Division: 210-280 working days; Priority review: 100-130 working days.&l...
South Africa : Drugs
<p>An application for registration includes:</p> <p>-Labeling information (package insert, patient information leaflet, label).<b...
Malawi: Vaccines
<p>Pharmacy, Medicines, and Poisons Board (PMPB) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals ar...
Malawi: Diagnostics
<p>0 clinical trials have been approved from August 2012 to August 2014.</p>
Rwanda: Vaccines
<p>USAID's assessment "<a href="http://apps.who.int/medicinedocs/documents/s18258en/s18258en.pdf" target="_blank"...
Rwanda: Drugs
<p>Approval from the Ministry of Health is required prior to a clinical trial taking place. Ethics committee review is required before approval ...