Ghana - Apply for Clinical Trials Quarterly Progress Report

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Procedure

Apply In-Person:

1. To Apply for the Clinical Trials Quarterly Progress Report in person, the applicant has to approach the Food and drugs authority (FDA) regional office in Accra Contact link
2. Applicant can be downloaded the application form this application link
3. All information sought in this form shall be provided to enable the FDA process the application.
4. 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.
5. The applicant has to make sure he or she has all the required documents that are required for this process to be successful and they can be found under the "Required Documents" section of this page.
6. A Fee for this procedure has to be paid as per the authority request.
7. The FDA will dispatch an inspector (medical officer) to the facility premises for inspection to determine if Good Manufacturing Practice (GMP) during the collection, testing, processing, storage, dispatch, quality control, and quality assurance of the products.
8. A copy of the report finding will be given to the applicant and if any modification or upgrading is required, Corrective Action and Preventive Action Report (CAPA) report will be issued and the applicant will be required to rectify the problem.
9. Upon successful implementation of the CAPA, a follow-up inspection may be conducted by the inspection team to ascertain the effectiveness of the implementation (where applicable).
10. If the authorized official is satisfied that all the conditions are met as required for the application, the applicant will be notified of the outcome and issued with the license.
11. The Processing time for this procedure is 1 month.

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Required Documents

• Application form link
• 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 landmarks.
• Any other documents that may be requested by the FDA.

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 Area,
SHIASHIE, ACCRA.
Contact link

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

Eligibility

• Hospitals and pharmacies in Ghana.
• Drugs and other regulated product manufacturers in Ghana.

Fees

• Refer to the FDA-approved structure fees link
  

Validity

• Permit to conduct clinical Trails validity for 2 years.

Documents to Use

• Application link
  

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

• Drug and other regulated product manufacturers are required to register and obtain a storage facility for drugs and other regulated product license from the food authority’s (FDA) after meeting the acceptable standards as set by the FDA before commencing operation.

Required Information

• Name of the organization
• 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, the highest standards of safety for all participants in EU clinical trials.

Information which might help

• The public health act 2012, act851 is enforced and the food and drug authority (FDA) exists to protect public health by assuring the safety, efficacy, and security of human and veterinary.

Other uses of the Document/Certificate

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

External Links

• More information can be obtained via link
  

Others

More information which might help people.