Go to main text

FDA

AK Science Research Intemational Co. AK Science Asia Co.,LTD

Although it is not possible to provide detailed guidance on all kinds of tests conducted in the Medical Device Industry, content measurements take up the most weight in the case of pharmaceuticals.
Regardless of the physical form of tablets, capsules, creams, lotions, liquids, etc., the main ingredients disclosed on the label are identified through crystallization analysis and the content specified on the package is confirmed by quantitative analysis.

Depending on the type of drug, if stipulated in the U.S. Pharmacopoeia (USP), it is additionally inspected for heavy metals, especially lead, mercury, and arsenic, which are harmful ingredients, exceeding the upper limit, and in many cases, microbiological safety inspection is also mandatory.

A microbiological safety inspection is to determine the total number of bacteria present in the product and whether it is contaminated with pathogens that can cause diseases such as escherichia coli, typhoid, staphylococcus, and pseudomonas. If the item has undergone a sterilization process, sterility is checked by attempting bacterial growth at room temperature and body temperature using the most sensitive medium.
Classification of Pharmaceuticals Based on the Regulatory Purposes
* New Drug Application (NDA: New Drug Application)
An application to obtain FDA approval in advance for the sale of a new drug, a newly developed compound or a substance that has not been used in medicine, never used, etc.
* Abbreviated New Drug Application (ANDA)
To seek approval of a generic drug (later drug), an application is submitted to obtain marketing approval in the future with the same drug as a new drug already on the market. Demonstration of bioequivalence is important.
* Investigational New Drug (IND)
- New drugs that are intended to be used only for the research by qualified experts with scientific training and experience to investigate the safety and effectiveness of drugs
It can be distributed or imported into the United States even if it does not get approval but it needs to be double-checked.
* Prescription Drugs
- It is prescribed or dispensed only according to the prescription of a licensed medical practitioner such as a doctor, dentist, or veterinarian. This drug must be labeled "Caution: Federal law prohibits dispensing without a prescription."
- General limited to prescription drugs when the drug can be safely used only under the supervision of a professional
* Nonprescription Durgs: OTC Drugs (Over-the-Counter Drugs)
" - It is a drug that is equivalent to Korean over-the-counter drugs and is sold on display in general pharmacies or supermarkets without a doctor's prescription, and is divided into about 80 categories including acne treatment and sunblock lotion."
- Almost all general products manufactured in South Korea can be obtained at a very low cost in a short time due to their classification as OTC drugs. Unlike prescription drugs or generic drugs, the approval process for OTC Drugs does not require clinical trials and can be distributed in the United States without any other approval process if only the OTC Monograph stipulated by the FDA is complied with.
* OTC Drug Monograph
In each of the 80 OTC drug categories, 800 active ingredients are included, and doses, formulations, labeling, testing, etc. are defined.
This monograph is constantly being updated as new ingredients and labeling regulations are added. If the monograph in each category is complied with, it can be distributed in the United States without other approval procedures.
In order to distribute products, prescription drugs, or their ingredients that do not comply with the OTC Drug Monograph as OTC Drugs, approval must be obtained through the NDA

※ Any foreign companies exporting drugs to the United States must register with the FDA to start the business. The number of foreign products imported into the United States is extremely limited no matter how perfect the product itself.