Kenya - Obtain Clinical Trials Letter of Approval

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Procedure

To obtain clinical trials letter of approval, the applicant has to contact the Pharmacy and Poisons Board offices.

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.

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.

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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

Pharmacy & Poisons Board (PPB) - Head Office
P.O. Box 27663 – 00506, Nairobi.
Address: Lenana Road Opp. DOD
Reception: +254 709 770 100
General Enquiries +254 709 770 100
General Enquiries:[email protected]
Pharmacy Questions:[email protected]
Report a Medicine Problem:[email protected]
About this website:[email protected]
Pharmacy and Poisons Board Contacts
Pharmacy and Poisons Board Website

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.

Fees

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Validity

365 Days

Documents to Use

Clinical Trial Application Form

Sample Documents

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Processing Time

1 Month

Related Videos

Videos explaining the procedure or to fill the applications. 
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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) 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.

Information which might help

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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