Important NAFDAC Regulations On The Registration of Bio-similars in Nigeria

Biochemicals :- Important Provisions Of The NAFDAC Regulations on the Registration of Bio-similars in Nigeria

Rendered effective from 13/12/2021, the National Agency For Food and Drug Administration and Control (NAFDAC) guidelines forming the focus of this article are aimed at the general public and Nigerian pharmaceutical industries in particular.

As with other NAFDAC regulations, it is important to state that no medicinal product shall be manufactured,imported, exported advertised, sold or distributed in Nigeria without necessary registration in compliance with laid-down NAFDAC regulations.

We will then be looking at the notable provisions of these guidelines.

Definition of Terms

– Reference Biotechnology Product (RBP) :- A product used as the comparator for head-to-head comparability studies with a Bio-similar in order to show similarity in terms of quality, safety and efficacy which must be licensed in Nigeria with some exceptions.

– Bio-similar – A product is said to be a biosimilar if it demonstrates similarity in terms of quality, safety and efficacy to a named reference bio-therapeutic product licensed in Nigeria and/or by s stringent regulatory authority. 

Applications

– The manufacturer shall be represented by an applicant – a duly registered pharmaceutical company – who must be in possession of a notarized power of attorney from the manufacturer authorizing him to speak for the principal on all matters relating to the product.

– The manufacturer must have:-

1. A manufacturer’s license/certificate :- This is the documentary evidence issued by a competent health authority of the country of manufacture that the company is licensed to manufacture biotechnological products which may be used in the country of origin/exported.

2. A product license/Certificate of registration.

3. A Certificate of Pharmaceutical Product(COPP) in conformity with WHO formats :- This is the documentary evidence by the competent health authority that the sale of the product does not constitute a contravention of the drug laws of the country of manufacture.

4. A valid World Health Organization (WHO) Certificate.

Product

– There must be evidence to demonstrate similarity to a named reference biotechnological product of assured quality, safety and efficacy in respect to the indication(s), note of administration and dosage forms that has been licensed based on a full registration dossier in Nigeria and or by w stringent regulatory authority.

– Failure to comply with this requirement will bar a product from registration.

Labelling Requirements

– The minimum labelling requirements on the primary and secondary package labels are :-

1. Name of product :- INN/Scientific name and brand name where applicable, which must be written directly under the brand name and in same character.

2. Manufacturer’s name and factory location address.

3. Provision for NAFDAC registration number.

5. Batch/Lot number.
6. Manufacturing and expiry dates.

6. Quantitative listing of all the active ingredients per unit dose.

7. Precisely defined storage conditions.

Documentation

– Applicants shall be required to submit the following documents (originals and 2 copies) along with the duly completed application forms to NAFDAC:-

1. Power of attorney or a contract manufacturing agreement.

2. Manufacturer’s license/Certificate indicating:-

– The name of products to be registered.

– The name and address of the manufacturer.

3. A certificate of pharmaceutical products (COPP- WHO format).

4. A valid WHO Good Manufacturing Practice (GMP) Certificate.

5. Evidence of trademark approval.

6. A comprehensive certificate of analysis, issued by the manufacturer indicating the name, designation and signature of the analyst.

7. Evidence of membership or approved sectoral group.

Validity period of Bio-similar Approval

– 5 years.

Fee Schedule

– Total regulatory payment for Bio-similar registration is 350 Thousand Naira plus 5% VAT( This is minus legal costs). 

Issuance of Certificate of Registration

– The applicant upon registration shall be issued a notification of product registration with the registration number which shall be subsequently used to obtain a registration certificate.