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Thailand: Diagnostics
<p>Mr. Chapon Ratanapan<br />Director<br />Medical Device Control Division<br />Tel: 66-2590-7254<br />Fax: 66-2591-8479...
China: Vaccines
<p>Estimated timelines differ for ordinary and fast track approval. CFDA has a flow chart of timelines available <a href="http://eng.sfd...
China: Diagnostics
<p>CFDA collaborates with the US Department of Health and Human Services on medical device regulation. Link to Memoranda of Understanding <a ...
Kenya: Drugs
<p>The manufacturer is responsible for applying to register a pharmaceutical product for manufacturing. There are six conditions for manufacture...
Kenya: Vaccines
<p>In 2008, Kenyan regulators participated in a joint review of the Phase III protocol for the RTS,S malaria vaccine, which was organized throug...
Kenya: Diagnostics
<p>Not applicable.</p>
Mozambique : Drugs
<p>Only drugs included in the National Formulary can be imported. Unauthorized drugs can be imported with special permission from the Ministry o...
South Africa : Vaccines
<p>Southern African Development Community (SADC).<br />African Medicines Registration Harmonization Initiative (AMRH).</p> <p>...
Mozambique : Vaccines
<p>Mozambique follows the South African Development Community's guidelines for regulating the conduct of clinical trials in human subjects a...
Vietnam: Drugs
<p>Vietnam uses the ASEAN Common Technical Dossiers (ACTD) application format for new drug registration.</p>
India: Vaccines
<p>All vaccines produced by recombinant DNA technology should follow Department of Biotechnology guidelines.</p>
India: Diagnostics
<p class="MsoNormal" style="margin-top: 6.0pt; margin-right: 0in; margin-bottom: 6.0pt; margin-left: 0in;"><strong><...
India: Drugs
<p><strong><em><span style="color: #ff0000;">Important Notice: Please note that the Union Health Ministry in India h...
Vietnam: Diagnostics
<p>The DMEHW will accept foreign clinical trial results if the device has been accepted and is registered in the country of origin. The results ...
Tanzania : Drugs
<p>After receiving a clinical trial certificate, an investigator can apply for an import/export permit from TFDA. Full requirements are outlined...
Uganda : Drugs
<p>A Clinical Trial License is required to import a product for purpose of clinical trial. This is granted by the NDA. More details are outlined...
Brazil: Drugs
<p>Pan American Health Organization (PAHO)/Pan American Network for Drug Regulatory Harmonization (PANDRH), MERCOSUR.</p>
Indonesia: Drugs
<p>Import authorization is granted after clinical trial application approval.</p>
Indonesia: Vaccines
<p>10 working days.</p>
Democratic Republic of Congo (DRC): Drugs
<p>Registration fee: USD 375<br />Laboratory analysis fee: USD 50</p>
Democratic Republic of Congo (DRC): Diagnostics
<p>La Direction des laboratoires de Sant&eacute; /Minist&egrave;re de la Sant&eacute;.</p>
Senegal: Drugs
<p>Import authorization can be requested from the Regulatory Authority after the CNRS opinion is given. Documents required for an importation li...
Nigeria: Diagnostics
<p>Application form: 250 N<br />Fee per medical device: 250,000 N + 5%VAT</p> <p>All fees made payable to NAFDAC.</p> ...
Argentina: Drugs
<p>90 working days.</p>
Bangladesh: Drugs
<p>Must submit an import license application.</p>
Nigeria: Drugs
<p><strong>Academic trials (Initiator-sponsored trials):</strong></p> <p><em>Imported Drugs, Locally Developed Dru...
Nigeria: Vaccines
<p>~90 working days.</p>
Brazil: Diagnostics
<p>International Medical Device Regulators Forum (IMDRF); MERCOSUR,&nbsp;Medical Device Single Audit Program (MDSAP).</p>
China: Drugs
<p>Import authorization is outlined in Chapter VI Section 1 of CFDA Order No. 28 ("Provisions for Drug Registration"). To apply to imp...
South Africa : Diagnostics
<p>South Africa does not have an official body that regulates medical devices. Electro-medical devices are an exception, which must be approved ...
Thailand: Drugs
<p>There is no centralized regulation of clinical trials in Thailand. Thai FDA does not directly regulate human clinical trials, rather it regul...
Uganda : Vaccines
<p>Phase I: $2500<br />Phase II or III (New investigational product): $4000<br />Phase II or III (Known product): $3000<br />P...
Uganda : Diagnostics
<p>A Clinical Trial License is required to import a product for purpose of clinical trial. This is granted by the NDA. More details are outlined...
Vietnam: Vaccines
<p>A manufacturer must obtain a<strong> Certificate of Satisfaction of Eligibility of Drug Business Conditions (Conditions Certificate)<...
Indonesia: Diagnostics
<p>4 clinical trials approved from June 2012 to June 2014.</p>
Tanzania : Vaccines
<p>Requirements to conduct clinical trials are outlined in&nbsp;<a style="color: #9a8d6a;" href="https://www.google.com/ur...
Tanzania : Diagnostics
<p>Requirements to conduct clinical trials are outlined in&nbsp;<a style="color: #9a8d6a;" href="https://www.google.com/ur...
Mali: Drugs
<p>7 clinical trials approved from June 2012 to June 2014.</p>
Mali: Diagnostics
<p>0 clinical trials approved from June 2012 to June 2014.</p>
Argentina: Vaccines
<p>According to&nbsp;<a href="http://www.anmat.gov.ar/Comunicados/Dispo_6677-10_en.pdf">Regulation 6677/10</a>, Applic...
Argentina: Diagnostics
<p>12 clinical trials approved from June 2012 to June 2014.</p>
Senegal: Vaccines
<p>Import authorization can be requested from the Regulatory Authority after the CNRS opinion is given. Documents required for an importation li...
Senegal: Diagnostics
<p>0 clinical trials approved from June 2012 to June 2014.</p>
Democratic Republic of Congo (DRC): Vaccines
<p>Registration fee: USD 375<br />Laboratory analysis fee: USD 50</p>
Rwanda: Diagnostics
<p>1 clinical trials approved from July 2012 to July 2014.</p>
Bangladesh: Vaccines
<p>14 clinical trials approved from June 2012 to June 2014.</p>
Brazil: Vaccines
<p>First, the study documentation must be translated into Portuguese (2-4 weeks). The clinical trial protocol must be approved by the institutio...
Malaysia: Drugs
<p>According to a presentation given by an employee of the NPCB, approval time takes:<br />EC/MoH: 6-8 weeks<br />Universities: 4-8 ...
Malaysia: Vaccines
<p>MYR 2000</p>
Malaysia: Diagnostics
<p>Regulatory framework is based on trends promoted by the Global Harmonization Task Force (GHTF), Asian Harmonization Working Party (AHWP) and ...