Introduction of REMS

In September 2007, the United States issued the Food and Drug Administration Amendments Act (FDAAA), which added a new risk reduction plan, the Risk Evaluation and Mitigation Strategy (REMS). REMS refers to the use of a series of off-label measures to ensure that the benefits of high-risk products outweigh the risks. Inappropriate use of these products can result in highly infectious, severe allergic reactions, liver and kidney injury, or reproductive toxicity. The purpose of REMS is to ensure that patients continue to have access to drugs that are relatively safe and clinically irreplaceable, with effective monitoring of known or potential risks.

FDA has the authority to require a marketing authorization holder to submit a REMS evaluation report at the time of registration of a new drug, if necessary. FDA also has the authority to require a drug marketing authorization holder to submit a REMS for a drug that has already been approved for marketing if there is new information about the safety of the drug.

Generic Drugs and REMS

The basis for approval of a generic drug is the demonstration through bioequivalence studies that there is no significant difference in the rate and extent of absorption between the generic drug and the reference listed drugs (RLD).

For REMS-regulated products, distributors are prohibited from selling to individuals or companies without permission. In this case, unless the generic manufacturer can purchase the product directly from the originator, there is no legal way to obtain RLDs to carry out subsequent R&D activities.

Our Compared Drugs

REMS is an effective tool to avoid uncontrolled risks to patients or potential users, but not all drugs require REMS. As a specialized drug wholesaler, Protheragen-ING is committed to sourcing all types of compared drugs (RLDs or innovator samples) globally.

• Wide range of sourcing channels

We have established close and long-term relationships with suppliers in the United States, Japan, and many other countries, and we source the products customers need as quickly as possible.

• High product quality

We have a professional supply chain and transportation conditions to ensure that drugs meet clinical study or bioequivalence requirements.

• Operational Compliance

We strictly follow regulations regarding drug procurement/transportation/handling regulations, and provide the legal origin of drugs to ensure traceability, including purchase contracts and shipping invoices.

• Price Advantage

We have rich experience in sourcing compared drugs and have a keen eye for market dynamics and drug demand changes. These capabilities enable us to offer significant price advantages for our products globally.

If you are interested in more information, please contact us.

Note:

• The products referred to herein are provided "as is" and Protheragen-ING makes no representation or guarantee of any kind regarding product specific information.
• The use of the products covered in this article may not be permitted under the relevant pharmaceutical regulations in some jurisdictions. Therefore, please check the relevant regulations in your jurisdiction first to determine whether you have the right to use these products.
• Protheragen-ING's basic premise for providing you with the products described herein is that you are solely responsible for ensuring your strict compliance with all applicable laws.