Month: December 2023

CERTIFICATE OF PHARMACEUTICAL PRODUCT(CPP) – AN OVERVIEW

CPP is the document that confirms a pharmaceutical product has met the quality, safety, and efficacy standards of the US FDA. CPP can be used to market pharmaceutical products in another country. Also, it helps to streamline the process by providing a summary of the technical data already reviewed and approved.

Pharmaceutical manufacturers and private label distributors who want to export their products to other countries are required to have CPP for their drugs.

Regulatory authorities in the importing countries may ask for CPP to ensure that the drug they are importing is following the regulations of the exporting country.

CPP contains the information about the product, such as its name, dosage form, and active ingredients, drug listing number, manufacturer information and the label image.

It contains a statement confirming the product’s marketing authorization status in the issuing country.

Benefits of getting CPP are getting faster registration process in other countries. Reduced costs for manufacturers by avoiding full re-evaluation of the product and improved access to essential medicines for patients in importing countries.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA drug establishment registration, drug listing and certificate to Pharmaceutical Product.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelphttp://www.fdahelp.us.us

COSMETIC OR DRUG

The classification of a product as a cosmetic or a drug by the U.S. FDA depends on its intended use of the product and how it is marketed. The products are regulated differently based on the classification.

Cosmetic:

As per FDA, a cosmetic is defined as a product “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s structure or functions.” Examples include skin moisturizers, perfumes, body cleansers, haircare products, moisturizers, and other skincare products.

FDA has introduced a new regulation under Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for registering the manufacturing facility with FDA and doing product listings.

Drug:

A drug is defined as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” This includes over the counter (OTC) medications, prescription drugs, and even some products marketed as dietary supplements.

Drugs are subject to more stringent regulatory requirements, including pre-market approval processes. They must demonstrate safety and efficacy before being allowed on the market.

It’s important to note that the intended use of a product, as determined by its marketing claims, is a key factor in determining its regulatory classification. If a product is intended to cleanse, beautify, or enhance appearance without making drug claims, it is likely to be classified as a cosmetic. If the product claims to treat or prevent a specific condition or disease, it may be classified as a drug.

However, some products, known as “cosmeceuticals,” may have characteristics of both cosmetics and drugs. These products claim to have therapeutic benefits but are often marketed as cosmetics. The classification can sometimes be nuanced, and companies must carefully consider their product claims and formulations to ensure compliance with FDA regulations.

If a product is classified as drug, then it must comply with all applicable drug regulations including establishment registration, cGMP and drug listing.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us