Ghana - Obtain a Permit to Conduct Clinical Trails

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Procedure

Apply In-Person:

1. Application form for Permit to Conduct Clinical Trails is available in the Food and drugs authority(FDA) regional office in Accra contact link
2. An applicant has to approach the FDA office and applicants can get their application form for permit to conduct clinical trials.
3. Read carefully through the application forms as there contain different section.
4. Applicant must make sure to carry all necessary documents that are mentioned under “Required Documents” section of this page. (Both photocopies and originals)
5. Please refer to the fees details in the “Fees” section of this page.
6. Please complete each section of this application form as a Word document then submit a printed version of the completed form, along with the supporting documents to the FDA regional office or the head office for verification and processing.
7. A CTD investigating panel/committee will be formed to investigate, if the clinical trials of benefit to the general public and that it will not harm them in any way and write a report on their finding.
8. The applicant may be summoned for an interview by the CTD investigation panel.
9. If the authorized official is satisfied with the report issued by the panel, stating that the product/drug Safety, quality and efficacy of the product/drug comply with conditions of registration, you will be notified of the approval and issued with the permit.
10. Generally, the processing time for this procedure is taken 1 month.

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Required Documents

• Application form
• Physical address with phone number and email address.
• All supporting documents as specified on the application form.
• Valid national identity card copy.
• valid company registration certificate copy of clinical trials
• A clinical trial protocol
• Financial declaration
• Analysis plan
• Material transfer agreement
• Insurance cover
• Investigation brochure
• Investigational product (IP) dossier
• License fee as stated in the food and drugs authority’s fees schedule.
• Sketch of exact directions to the dry food storage facility, indicating land marks.
• Any other documents that may be request by the FDA.

Note: A copy of the submitted documents shall be endorsed by the FDA and returned to the applicant.

Office Locations & Contacts

Cover Letter Addressed To:
The Chief Executive
Food and Drugs Authority
P.O. Box CT 2783
Cantonments – Accra
GHANA.

Return Completed Form To:
Chief Executive Officer,
Food and Drugs Authority,
17 South Legon Commercial Areas,
SHIASHIE, ACCRA.
Contact link

Location: Accra
Address: Food and Drugs Authority
Health consultant in Accra, Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
Contact number- +233 30 223 3200
Location link

Eligibility

• All Individuals /corporation/cooperative association are eligible.

Fees

Refer to the FDA approved structure fees link

Validity

• Permit to conduct clinical Trails validity for 2 years.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The Processing time for this procedure is taken 1 month.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• The Food and Drugs Authority (FDA), formerly, Food and Drugs Board (FDB) is the regulatory authority with the responsibility of implementing the Food and Drugs Law of 1992, (PNDCL 305b). Part seven of the Public Health Act, 2012, Act 851 mandates the Food and Drugs Authority (FDA) to protect and promote public health by ensuring that food and drugs consumed in Ghana are wholesome and safe.

Required Information

• Name of the company
• Mailing address of company( include location of the post office)
• Physical address: (include legal name , number, street , city and district)
• Contact detail(telephone /fax number, email address)
• Contact person’s information (legal name/email/telephone)
• List and other certificate for your procedure.
• Monitor details
• Pharmacist details
• Trail details
• Sponsor details
• Number of employees
• Declaration

Need for the Document

• It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials. The key benefits of the Regulation include increased transparency of information on clinical trials, highest standards of safety for all participants in EU clinical trials.

Information which might help

• The Food and Drugs Authority (FDA), 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.
• FDA 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.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

More information which might help people.