RAGULATORY AFFAIRS:

Regulatory submission processes:

The submission must be produced and lodged with all relevant regulatory bodies to seek
assessment and, eventually, regulatory clearance before a novel medicine or biologic can go
to market.

1- Review and approval procedures :

a) Pre-submission meeting

b) Pre-submission activities

c) Administrative review

d) Agency review and sponsor response

e) Activities prior to the agency’s decision

f) Decision

Unlicensed and licensed products:

Advertising and promotion

Unlicensed healthcare products:

There is no advertising or promotion permitted. Unlicensed health care items are prohibited
from being advertised or promoted internationally. “No person shall mark, pack,
manufacture, prepare, trade, or distribute any drug in a manner that is false, misleading, or
deceptive, or that is likely to generate an erroneous impression regarding its composition,
merit, or safety,” says Section 9(1) of the Food and Drugs Act in Canada. Unlicensed
healthcare goods cannot be advertised because the terms and any intended indications
have not been established. The advertising of any experimental medication or medical
device is expressly forbidden under the US Code of Federal Regulations (CFR), Title 21,
section 312.7(a) and 812.7(a).

Why the promotion or advertising of unlicensed healthcare products is

prohibited ?

The main concern with the promotion or advertising of unlicensed healthcare products or
off-label uses is that a healthcare provider may form an opinion about a product's use based
on its company's claims before it receives regulatory approval, and that opinion may be
incorrect in relation to the pending regulatory approval. Such an erroneous opinion on the
part of the healthcare provider could lead to improper use of the licensed medicine,
resulting in off-label usage of the product.
Advertising licensed healthcare products

An advertisement is defined as "any representation by any means whatever for the purpose
of encouraging directly or indirectly the sale or disposal of any food, drug, cosmetic, or
gadget," according to Section 2 of Canada's Food and Drugs Act.

Promotion can take on many forms, including

 Advertisements
 Internet sites
 Brochures
 Exhibition panel
 Gifts
 Samples
 Reprints
 Product monographs
 A sales representative’s activities
 Training materials or briefings
 Press releases
 Meetings or symposia

Different regulatory bodies have different views on advertising healthcare products :

 To protect the public from fraudulent and misleading healthcare

promotional efforts, regulatory procedures have been put in place.
Furthermore, these systems range between jurisdictions in terms of
what constitutes advertising and promotional activities, and as a result,
their legislation and enforcement varied as well. Understand the local
standards to ensure compliance with industry regulations.
 Advertising in Canada is mostly self-regulatory, with materials
submitted for pre-approval on a voluntary basis. In circumstances
where advertising may pose a substantial health threat, such as when
a prescription drug is illegally advertised to the general public or an
unlicensed health product is pushed, Health Canada is ultimately
accountable for enforcement.