Safeguarding Public Health Through Comprehensive Regulation

MoH

Ministry of health of Rwanda

MoH Website 

https://www.moh.gov.rw/

Regulatory Agency

Rwanda food and Drug authority

Regulatory Agency Website 

Local Authorized Representative

Yes

License Validity

5 years

License Renewal

90 days before the expiry date

Timeline for Registration 

Approx. 9 months.

Regulation

Law nº 003/2018 of 09/02/2018 Rwanda FDA

Fees

Registration for human medicines (foreigner) is 1,250 USD

Registration Requirements

CTD format with English language.

Registration of Medicinal Products

Application for registration of medicinal product

• Made to the drug registration authority i.e. Rwanda food and drug authority in written by marketing authorisation holder, manufacturer or local authorized representative.
• Each pharmaceutical product having an individual active component, strength, dosage form, manufacturing site, or proprietary name must submit a full and distinct application for registration.
• Applications for the registration of pharmaceuticals must include data proving the product’s effectiveness, safety, and quality, as well as meeting the technical specifications set out by the Authority in the applicable Guidelines.
• Applications and submitting documents should be submitted in English Language.

 Application Requirements

An application for human product should include:

1. Signed and dated original hard copy of cover letter
2. Signed and dated application form for product registration
3. Proof of payment of registration fee at the time of submission

 Two CD-Rom containing CTD document Format in (PDF), QOS, QIS, in MS-Word 5. Two commercial samples of the FPP with CoAhttps://rwandafda.gov.rw/

Documents required for registration of medicinal Product

Follow Guidelines No DHT/GDL/001.

• Module 1: Administrative and Prescribing Information (country specific).
• Module 2: Overviews and summaries (module2-5)
• Module 3: Quality.
• Module 4: Non-Clinical Study Report
• Module 5: Clinical Study report

Assessment process of medicinal Process

1. After the application satisfies the Authority, complete or condensed evaluation methods may be used to ensure compliance with safety, quality, and effectiveness standards. Guidelines, SOPs, forms, and tools for both comprehensive and condensed evaluation procedures must be established by the authority.
2. During the assessment, the Authority may ask the applicant to provide further samples, documents, data, or clarification that supports the registration application.
3. The application processing won’t start until the applicant submits additional samples, documents, information, and data and or clarification in accordance with paragraph b.
4. If an applicant fails to submit the additional documents or info asked by the authority within 90 days from the date of request letter, the application will be considered as withdrawn.
5. In accordance with the requirements of point d, the applicant may, (by providing justification in writing) request an extension of time for submitting any more samples, documents, information, data, or explanation that the Authority may request.
6. If the applicant fails to provide satisfactory responses to the requested information according to point b for a fourth time, the application will be denied.
7. An application that is withdrawn in accordance with point d will only be taken into consideration for registration if a new application is submitted in accordance with these Regulations’ requirements.

Approval of medicinal Products

Following approval of the registration of a medicinal product, the Authority will:

• Enters the prescribed details of the medicinal product in the register;
• Assigns the medicinal product a registration number; and

 Issue a certificate of full or conditional registration in the prescribed format to the holder of the marketing authorization.