Yes, provided there is similarity in the dissolution profile of the test and reference products and the excipients are the same.
There is a Regulatory Directive on Discontinuation of Registration of some Fixed Dose Combinations (FDC) on NAFDAC website.
In addition to the innovator products, products on WHO COMPARATOR LIST (https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Events/Presentations/Mr-Dennis-Ake-Brief-of-Bioequivalence-study.pdf) can be used as reference product for the purpose of BE studies.
Data on clinical data is required mainly for innovator products while BE data is required for generic products. For an innovator product, real time clinical data rather than literature search, is required.
Biowaiver is applicable to product in BCS classes 1 and 3 only. The efficacy of such ingenious formulation will have to be demonstrated through BE studies.
Application for renewal is made via the NAPAMS portal. The Guideline for Renewal of Certificate for Registration of Drug Products is on our website.
With the plan to open the window three times in a year an applicant will have the opportunity to submit up to nine dossiers in a year. In addition to this, local manufacturers are allowed to submit more dossiers outside the normal submission cycle.
Products not on Federal government import prohibition list, NAFDAC Ceiling list, Regulatory Directive on Discontinuation of Registration of some Fixed Dose Combinations (FDC), https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Note_To_Industry_2024/PRODUCTS-FOR-55-VALIDITY-POLICY.pdf and not included in any of the Regulatory directive may be imported so long as the registration requirements are met.
The number of applications accepted when the window for dossier submission opens affects the numbers of times the window can be opened in a year. For NAFDAC to be able to maintain three cycles of dossier submissions in a year it is important the number of dossiers accepted per cycle is not more than 300.
Product in solution generally do not require BE studies. However, BE studies are required for suspensions as per ICHM13A guideline.
Yes, it is mandatory to register your company Corporate Affairs Commission to do business in Nigeria. Some details from your registration would be needed to proceed on NAFDAC electronic platform(s).
It is the responsibility of the applicant to know which BCS class his/her drugs belong and whether they meet with biowaiver requirements or not. ICH M9 provides guidance of BCS classification. NAFDAC has however compiled a list of common drugs that are eligible for biowaiver.
You will be required to submit BE for the higher strength and additional strength biowaiver for the lower strength.
Diclofenac Sodium injection is allowed for submission.
Please refer to the list of Regulatory Directive on Discontinuation of Registration of some Fixed Dose Combinations (FDC) on NAFDAC website for further clarification.
The innovator product depends on the particular product in question. In addition to the innovator brands, products on WHO comparator list can be used (https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Events/Presentations/Mr-Dennis-Ake-Brief-of-Bioequivalence-study.pdf).
All products containing solvents that have high risk for contamination with Ethylene glycol and Diethylene glycol are classified as high risk. Such dossiers are expected to include test for EG and DEG in the specifications for these solvents. These solvents include but not limited to Polyethylene Glycol, Sorbitol, Mannitol etc. Click here for more information
No, Omeprazole cannot be renewed as they are expected to be manufactured local same as products on the NAFDAC ceiling list.
Refer to the product registration guidelines on the NAFDAC website at https://nafdac.gov.ng/regulatory-resources/guidelines/
Annual Product Quality Review is for already registered products and need not be submitted for new applications at the stage of registration.
For rejected dossiers, the applicant can resubmit during the next window after addressing those issues for which the dossier was rejected.
Window opening will no longer be based on a number of days, but on number of applications. As soon as the required number of 300 dossiers are received the window closes automatically.
Drug registration has several components such as GMP audit, Dossier review and laboratory analysis. The three are complimentary and not mutually exclusive. A drug product is registered when the applicant has satisfied the requirements of all the registration components including satisfactory GMP, dossier Assessment, as well as satisfactory laboratory evaluation .
