Clinical Trials are important in helping discover new medicines to diagnose, treat, manage or prevent the many diseases affecting the human beings. The studies are also used to determine whether to change the initial indications, dosage or even the age group of the initially approved medications.
To support the registration of these medicines, the studies need to be carried out according to the approved protocols. These studies should also be monitored/inspected to ensure the integrity of the data generated. In addition, these studies should be conducted in accordance with the regulatory requirements and GCP standards. The Pharmacy and Poisons Board as the National Medicines Regulatory Authority, regulates Clinical Trials taking place in the country.
The sponsors, prospective researchers or principal investigators should apply to the Board after obtaining Ethical favourable opinion / Approval from one of the NCST-accredited ethical committees. In addition one needs to make his / her application by completing the prescribed application form and ensuring that all the requirements as indicated in the checklist are met.
The Pharmacy and Poisons Board through the Experts Committee on Clinical Trials strives to review the protocol and provide a response to the applicant within 30 working days as indicated in the Service Charter.
Going forward, applicants will be able to submit their applications online which will improve efficiency in reviewing the proposals.
Other researchers and the public will be able to know which clinical trials, which diseases and in what part of the country the studies are taking place apart from being able to track their protocol upon submission.
- Guidelines for carrying out clinical trials in Kenya
- The New applications checklist
- Checklist for Annual Approval
- Declaration by Applicant
- Financial Declaration