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How to Obtain Clinical Trials Letter of Approval in Kenya

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How to Obtain Clinical Trials Letter of Approval in Kenya by Kenyans247(m): Sat Feb 2020 08:36am
Procedure
To obtain clinical trials letter of approval, the applicant has to contact the Pharmacy and Poisons Board offices. http://pharmacyboardkenya.org/?page_id=99

The applicant has to make sure he or she has all the required documents that are required for this process to be successful and it can be found under the "Required Documents" section of this page or in the Application Form. http://pharmacyboardkenya.org/downloads/?file=Guidelines%20for%20Conduct%20of%20Clinical%20Trials%20in%20Kenya%202016.pdf

Application
All applications to conduct a clinical trial will be received at the Clinical Trial Unit of Division of Medicines Information and Pharmacovigilance of the Pharmacy and Poisons Board.
On receipt, the application will be screened for completeness prior to acceptance according to the receipt SOP (PPB/MIP/CLT/SOP/003).
Application Reference Number:
When an application for a Clinical Trial is accepted, an acknowledgement of receipt will be issued with a reference number for each application. This PPB/ECCT reference number must be quoted in all correspondence concerning the application in the future.

Review
Applications will be reviewed according to Standard Operating Procedures of the Unit (PPB/MIP/CLT/SOP/004, PPB/MIP/CLT/SOP/005)
Each member prior to reviewing the application will declare conflict of interest in the study and should have no financial or personal interests, which could affect their impartiality.
The reviewers shall be independent of the sponsor, of the clinical trial site and the investigators involved and of persons financing the clinical trial, as well as free of any other undue influence
Confidentiality will be maintained at all times during review.
PPB may approve the trial application or reject it specifying reasons for rejection.
The decision of the PPB (Approval, Request for Additional Information or Rejection) will be communicate to the applicant within 30 working days of the receipt of a complete and valid application
In the case of rejection, the applicant may appeal and provide additional information to satisfy PPB requirements. In specific cases, PPB may decide to refer the matter to external experts for recommendation.
The review shall consider among other things;
Reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints;
Compliance with the requirements concerning the manufacturing and import of investigational medicinal products and auxiliary medicinal product,
Compliance with the labelling requirements;
The completeness and adequateness of the investigator's brochure.
All decisions will be communicated to the applicant in writing stating whether the trial has been approved as it is, or if it requires certain corrections or if it has been rejected within 1 Month.

Required Documents
Cover letter
Completed application form
The Study Protocol
Patient Information leaflet and Informed consent form
Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD)
Adequate data and information on previous studies and phases
Stability data of the investigational product
GMP certificate of the investigational product from the site of manufacture
Certificate of Analysis of the investigational product
Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used
Signed investigator(s) CV(s) including that of study Pharmacist
Evidence of recent GCP training of the core study staff
DSMB Charter including the composition and meeting schedule
Detailed budget of the study
Financial declaration by Sponsor and/or PI
Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to protocol and applicable laws and regulations.
Indemnity cover for PI and investigators
Insurance Certificate for the participants
Copy of favorable opinion letter from the local Ethics Review Committee (ERC).
Copy of current Practice Licenses for the Investigators and study Pharmacist
Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
Where the trial is part of an international study, sufficient information regarding the other participating countries and the scope of the study in these countries.
For multicentre/multi-site studies, an addendum for each of the proposed sites including among other things the sites capacity to carry out the study i.e personnel, equipment, laboratory etc
Registration at the clinical trial registry at www.ctr. pharmacyboardkenya.org
A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading.
Payment of fees
Four bound hard copies of all the above documents
Signed checklist

Office Locations & Contacts
The Registrar
Pharmacy and Poisons Board

Lenana Road Opp. DOD

P.O. Box 27663 00506

Nairobi

Telephone:
+254 702 475 824 (8am-5pm) Online Licensing
+254 702 475 845 (8am-5pm) Online Licensing
+254 702 475 837 (8am-5pm) Online Licensing
+254 702 475 842 (8am-5pm) Online Licensing
+254 702 475 801 (8am-5pm) Online Licensing
+254 20 3562107 General Line
+254 720 608811 General Line
+254 733 884411 General Line

Email:
General Enquiries: enquiries@pharmacyboardkenya.org
Pharmacy Questions: info@pharmacyboardkenya.org
Report a Medicine Problem: pv@pharmacyboardkenya.org

Website: http://pharmacyboardkenya.org

Map Location https://www.google.com/maps/place/Pharmacy+and+Poisons+Board,+Kenya

Eligibility
Any person wishing to carry out a clinical trial in the country should apply to the Board for approval before engaging in such study involving investigational products.

Validity
365 Days

Documents to Use
Clinical Trial Application Form http://pharmacyboardkenya.org/downloads/?file=clinical_trial_application_form.pdf

Processing Time
1 Month


Instructions
An application to conduct a clinical trial is required for any study that intends to use human subjects for the testing of:
Unregistered medicines, vaccines or medical devices
Registered medicines where the proposed clinical trials are outside the conditions of approval for registration. These may include changes to:
Indications and clinical use
Target patient population(s)
Routes of administration
Dosage regimens
Comparative bioavailability trials
Studies intended to generate data on a product that is registered in Kenya based on foreign generated data.
Studies to establish Bioequivalence for registration of generic products
Studies to identify any adverse reactions to one or more medicinal products
Studies to generate information on the absorption, distribution, metabolism and excretion of one or more medicinal products;
Or any study that is going to use an investigational product/medicine/device on human beings.
Post- Marketing clinical trials (Phase IV) of registered medicines
An application to conduct a clinical trial should be made by the sponsor or sponsors representative and is known as the Applicant.
For multi site trial in Kenya, there shall only be one application by the Sponsor but there shall be Coordinating PI who shall be responsible for all the sites. In addition, the application should have the site specific addendum which should have the details of the sites including the infrastructure and staff capability to conduct the study.
An application must be made by completing the appropriate application form (Annex 1; FOM 001/MIP/CLT/014) http://pharmacyboardkenya.org/downloads/?file=clinical_trial_application_form.pdf and submitting this together with the required supporting documents and an application fee of USD 1,000.00 (or its equivalent in Kenya Shillings at the prevailing bank rates) Application forms and application guidelines can be downloaded from the PPB website: http://pharmacyboardkenya.org/?page_id=401
An application to conduct a clinical trial shall include all the documents as indicated in Annex 2 (FOM 001/MIP/CLT/015)

Required Information
Number of sites
Participants (subjects)
Age span
Group of trial subjects
Gender
Co-ordinating investigator (for multicentre trials in kenya)
Principal investigator (for multicentre trial)
Organisations to whom the sponsor has transferred trial related duties and functions
Principal inclusion criteria
Scope of the trial
Trial type and phase
Design of the trial

Need for the Document
The Pharmacy and Poisons Board recognizes the importance of Research and Development of new medicines, medical devices or procedures in the attainment of national health, social and economic goals. Clinical research must nonetheless be conducted under conditions that satisfy ethical and scientific quality standards.

PPB will endeavour to provide a regulatory environment that avoids unnecessary delays in the clinical trial authorization process while providing safeguards for quality, efficacy, and public health.

Source https://www.wikiprocedure.com/index.php?title=Kenya_-_Obtain_Clinical_Trials_Letter_of_Approval

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